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Adverse Event Report

DISETRONIC MEDICAL SYSTEMS, INC. PUMP ADAPTER (USED WITH H-TRONPLUS) INSULIN PUMP ADAPTOR   back to search results
Catalog Number ADP3000418
Event Date 12/28/2003
Event Type  Malfunction  
Event Description

Pt alleged that leaking device accessory impeded insulin delivery, resulting in pt having a high blood glucose reaction (glucose monitor read "hi", and they experienced vomiting). Pt unsuccessfully attempted to self-treat by delivering an insulin bolus. Pt then gave themselves insulin injections.

 
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Brand NamePUMP ADAPTER (USED WITH H-TRONPLUS)
Type of DeviceINSULIN PUMP ADAPTOR
Baseline Brand NamePUMP ADAPTER (USED WITH H-TRONPLUS)
Baseline Generic NameINSULIN PUMP ADAPTOR
Baseline Catalogue NumberADP3000418
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DISETRONIC MEDICAL SYSTEMS, INC.
5151 program ave.
st. paul MN 55112 1014
Manufacturer (Section D)
DISETRONIC MEDICAL SYSTEMS, INC.
5151 program ave.
st. paul MN 55112 1014
Manufacturer (Section G)
DISETRONIC MEDICAL SYSTEMS AG
brunnmattstrass 6
burgdorf
SWITZERLAND CH-3401
Manufacturer Contact
debara reese
5151 program avenue
st. paul , MN 55112-1014
(317) 521 -3857
Device Event Key506261
MDR Report Key517226
Event Key490812
Report Number2183996-2004-00010
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Remedial Action Replace
Type of Report Initial
Report Date 12/28/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberADP3000418
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 Received12/28/2003
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
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 Unkown

Patient TREATMENT DATA
Date Received: 01/30/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,INSULIN, INSULIN INFUSION SET
DATE OF,
2,TREATMENT: NA.,

Database last updated on February 28, 2009

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