FDA.reportPublic FDA data

MAUDE MDR 9908477

MDR report key
9908477
Report number
3004209178-2020-92408
Event key
0
Event type
3
Date of event
2020-03-22
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
1630G INSULIN PUMP MMT-1715K 630G BLACK MGARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPENDMEDTRONIC PUERTO RICO OPERATIONS CO.OZOMMT-1715KMMT-1715KHG1YZBS* N

Patients#

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

Event Narratives#

N

Patient 1

CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

D

Patient 1

INFORMATION INDICATED BY MEDTRONIC THAT THE RETAINER RING WAS DAMAGED. CUSTOMER STATED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

N

Patient 1

DEVICE WAS RECEIVED WITH PARTIALLY BROKEN RESERVOIR TUBE LIP, MISSING RETAINER AND MISSING RESERVOIR TUBE O-RING. A TEST P-CAP AND RESERVOIR WAS INSTALLED AND DID NOT LOCK IN PLACE DUE TO BROKEN RESERVOIR TUBE LIP AND MISSING RETAINER. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO BROKEN RESERVOIR TUBE LIP AND MISSING RETAINER.