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Adverse Event Report

DISETRONIC MEDICAL SYSTEMS RAPID-D INFUSION SET INSULIN INFUSION SET   back to search results
Catalog Number 3000953
Event Date 03/16/2004
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention
Event Description

Reporter stated that patient went to hosp due to high blood glucose (in the 300's [mg/dl]) and vomiting. Patient was unable to reduce blood glucose themselves, and ketones tested as "large. " patient was treated with iv insulin.

 
Manufacturer Narrative

D9: infusion set in use at time event was discarded, but remaining infusion sets from box will be returned by the patient for evaluation.

 
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Brand NameRAPID-D INFUSION SET
Type of DeviceINSULIN INFUSION SET
Baseline Brand NameRAPID-D INFUSION SET
Baseline Generic NameINSULIN INFUSION SET
Baseline Catalogue Number3000953
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DISETRONIC MEDICAL SYSTEMS
5151 program ave.
st. paul MN 55112 1014
Manufacturer (Section D)
DISETRONIC MEDICAL SYSTEMS
5151 program ave.
st. paul MN 55112 1014
Manufacturer (Section G)
DISETRONIC MEDICAL SYSTEMS AG
brunnmattstrasse 6
burgdorf
SWITZERLAND CH-3401
Manufacturer Contact
debara reese
5151 program avenue
st. paul , MN 55112-1014
(317) 521 -3857
Device Event Key507898
MDR Report Key518868
Event Key492363
Report Number2183996-2004-00180
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Remedial Action Replace
Type of Report Initial
Report Date 03/22/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date03/01/2008
Device Catalogue Number3000953
Device LOT Number174213
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received03/22/2004
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/01/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,INSULIN, INSULIN INFUSION PUMP
DATES OF TREAMENT:,
2 2004. 01/01/2004

Database last updated on January 30, 2009

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