FDA.reportPublic FDA data

MAUDE MDR 9908924

MDR report key
9908924
Report number
3004209178-2020-92490
Event key
0
Event type
3
Date of event
2020-01-28
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-1715KHG2MEGQR R

Patients#

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

Event Narratives#

N

Patient 1

THE PUMP WAS RECEIVED WITH PARTIALLY BROKEN RESERVOIR TUBE, MISSING RETAINER, MISSING RESERVOIR TUBE O-RING, ASE CRACKED BEHIND THE PUMP AT THE CORNER OF THE BELT CLIP RAILS AND CRACKED BATTERY TUBE THREADS. 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. (B)(4).

D

Patient 1

INFORMATION RECEIVED BY THE MEDTRONIC INDICATED THAT THE INSULIN PUMP'S TOP OF BATTERY COMPARTMENT HAD CRACK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.