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Adverse Event Report

DISETRONIC MEDICAL SYSTEMS INC. D-TRONPLUS INSULIN INFUSION PUMP   back to search results
Model Number D-TRONPLUS
Event Date 03/24/2004
Event Type  Malfunction  
Event Description

Patient reported that device made a loud clanking sound and was vibrating when they set the device up to deliver a bolus. Patient stated that bolus was delivered, but when they disconnected device from infusion site and bolused in the air, no insulin dripped from the tubing. No treatment was received as a result of this incident (patient's blood glucose was not affected).

 
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Brand NameD-TRONPLUS
Type of DeviceINSULIN INFUSION PUMP
Baseline Brand NameD-TRONPLUS
Baseline Generic NameINSULIN INFUSION PUMP
Baseline Catalogue Number8100130
Baseline Model NumberD-TRONPLUS
Baseline Device FamilyD-TRONPLUS
Baseline Device 510(K) NumberK022831
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed10/21/2002
Manufacturer (Section F)
DISETRONIC MEDICAL SYSTEMS INC.
11800 exit 5 pkwy
ste 120
fisher IN 46038
Manufacturer (Section D)
DISETRONIC MEDICAL SYSTEMS INC.
11800 exit 5 pkwy
ste 120
fisher IN 46038
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 Key535247
MDR Report Key545819
Event Key518454
Report Number2183996-2004-00187
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/24/2004
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? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberD-TRONPLUS
Device Catalogue NumberPMR81001XX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2004
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received03/24/2004
Was Device Evaluated By Manufacturer? Yes
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: 09/06/2005 Patient Sequence Number: 1
#TreatmentTreatment Date
1,1. INSULIN,
2,2. INSULIN INFUSION SET
DATE OF TREATMENT: NA.,

Database last updated on December 31, 2008

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