FDA.reportPublic FDA data

MAUDE MDR 9908852

MDR report key
9908852
Report number
3004209178-2020-92455
Event key
0
Event type
3
Date of event
2018-02-16
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-1711KPUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSORMEDTRONIC PUERTO RICO OPERATIONS CO.OYCMMT-1711KMMT-1711KHG21KG0R R

Patients#

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

Event Narratives#

N

Patient 1

UNIT RECEIVED WITH CRITICAL PUMP ERROR DUE TO CORRODED ELECTRONIC ASSEMBLIES. UNIT RECEIVED WITH CORRODED MOTOR HOME SWITCH, CRACKED BATTERY TUBE THREADS, CRACKED RETAINER AND CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT. THE P-CAP DOES LOCK PROPERLY 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. (B)(4).

D

Patient 1

INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CRACK WAS SEEN ON BATTERY BACKSIDE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.