FDA.reportPublic FDA data

MAUDE MDR 9908907

MDR report key
9908907
Report number
3004209178-2020-92482
Event key
0
Event type
3
Date of event
2019-10-03
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
GERWIN DE GRAAFF
Address
CEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777 *
Phone
818-818-8185
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1640G INSULIN PUMP MMT-1712KPUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSORMEDTRONIC PUERTO RICO OPERATIONS CO.OYCMMT-1712KMMT-1712KHG2VB62R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

(B)(4). UNIT RECEIVED WITH MISSING RETAINER RING AND RESERVOIR TUBE LIP O-RING. UNABLE TO PERFORM DISPLACEMENT TEST AND P-CAP / RESERVOIR WILL NOT LOCK PROPERLY DUE TO MISSING RETAINER. UNIT PASSED SELFTEST, SLEEP CURRENT MEASUREMENT, AND ACTIVE CURRENT MEASUREMENT. NO BATTERY OR POWER ANOMALIES NOTED DURING TESTING OR IN POWER GRAPH, HOWEVER UNIT RECEIVED WITH CORRODED BATTERY TUBE. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

D

Patient 1

INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BATTERIES END AFTER ONE DAY THE BATTERY CAP WAS OK AND WAS USING BATTERIES FROM GOOD QUALITY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.