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Adverse Event Report

DISETRONIC MEDICAL SYSTEMS, INC. H-TRONPLUS V100 INSULIN INFUSION PUMP   back to search results
Model Number H-TRONPLUS V-100
Event Date 06/08/2001
Event Type  Injury   Patient Outcome  Hospitalization;
Event Description

Pt treated at hosp for hyperglycemia. Pump was not returned for eval.

 
Manufacturer Narrative

Disetronic could not evaluate the pump, as the pt did not return it. User error likely caused event. Continuous insulin infusion therapy (ciit) requires that the pt continually assess the impact of such factors as their caloric intake, activity levels and other medical conditions and/or treatments on their blood glucose level. The therapy also requires periodic self-testing of actual blood glucose levels. Failure to montior and/or adjust the insulin amount appropriately will result in erratic blood glucose levels. Extreme excursions from normal blood glucose levels can result in conditions such as hypoglycemia or hyperglycemia. Pts experiencing these conditions may require hospitalization and medical intervention to preclude serious medical conditions including death.

 
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Brand NameH-TRONPLUS V100 INSULIN INFUSION PUMP
Type of DeviceINSULIN INFUSION PUMP
Baseline Brand NameH-TRONPLUS V100 INSULIN INFUSION PUMP
Baseline Generic NameINSULIN INFUSION PUMP
Baseline Catalogue Number805.0029
Baseline Model NumberH-TRONPLUS V-100
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DISETRONIC MEDICAL SYSTEMS, INC.
5151 program avenue
st. paul MN 55112 1014
Manufacturer (Section D)
DISETRONIC MEDICAL SYSTEMS, INC.
5151 program avenue
st. paul MN 55112 1014
Manufacturer Contact
david chadwick, ph.d
5151 program avenue
st. paul , MN 55112-1014
(612) 795 -5200
Device Event Key331014
MDR Report Key341678
Event Key321741
Report Number2183996-2001-00039
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Remedial Action Other
Type of Report Initial
Report Date 06/12/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL NumberH-TRONPLUS V-100
Device Catalogue Number805.0022
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/12/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 07/13/2001 Patient Sequence Number: 1
#TreatmentTreatment Date
1,INSULIN
INSULIN INFUSION SET
,
2,DATES OF TREATMENT - NA.,

Database last updated on February 28, 2009

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