FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule

Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

DISETRONIC MEDICAL SYSTEMS, INC. DISETRONIC H-TRON V-100 INSULIN PUMP   back to search results
Model Number H-TRON V-100
Patient Outcome  Life Threatening;
Event Description

While inpatient for cystic fibrosis, had a hyopglycemic event. Pt was awakened at 0600 for a pre-breakfast finger stick, value was 108 approx. At 0700 resiratory therapist arrived for chest therapy. At 0730 pt fell back to sleep while waiting for breakfast tray. That is the last event pt remembers. At 1030 a diabetic clinical nurse came in to apply a continuous glucose monitor, pt has cystic fibrosis related diabetes and their glucose levels have always been irratic and high. The nurse found pt in what she believed,was a sleeping state. Spoke to pt to waken pt, pt nodded their head and she left to do charting. When she returned some 10 minutes later pt was still in the same position, she went over to pt to pull pt to a sitting position and pt was extremely diaphoretic. She called for help. Other nurses came with juice and glucose monitor. Finger stick value was 20. D-50 was also administered and pt gained consciousness. Pt recalls nothing after falling asleep at 0730. Pt insulin pump, disetronic h-tron v-100 ref# 805. 0064us, was removed by the diabetic nurse. She called disetronic co to have them talk her through the steps to get to the history part of their pump. It was determined that at approx. 0830-0900 a bolus of 10 units was given. Pt recalls none of this. It would take at the least 21 pushes of the buttons on their pump to prime it for a bolus of 10 units. In a sleeping state or unconscious states from a hypoglycemic event pt doesn't feel pt initiated that bolus. With a f. S. Of 108 at 0600 pt knew pt was within normal limits and would not have given self insulin until pt was eating breakfast. Reporter has done some research on web page and found that this co has had two models recalled for boluses that were not initiated by the pt. Also that their model pump is in a form of recall for "reason-lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water. " that last statement was copied from report. Pt was informed not to expose to water only. Approx. 3 weeks prior. While home pt did have an event similar to the above described event. Pt was diaphoretic and not making sense while taking. It happened again in their sleep at 0330. F. S. Value was 27. Had pt drink regular soda and was fine. Reported this to their physician during pt hosp stay. Did not call co about the event, at that time did not know of any recalls or problems with the pumps initiating boluses on their own.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameDISETRONIC
Type of DeviceH-TRON V-100 INSULIN PUMP
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DISETRONIC MEDICAL SYSTEMS, INC.
st. paul MN 55112 1014
Device Event Key495344
MDR Report Key506473
Event Key480375
Report NumberMW1030672
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Report Date 12/23/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberH-TRON V-100
Device Catalogue NumberREF# 805.0064US
OTHER Device ID NumberID420.0545/V02/05.
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH