FDA.reportPublic FDA data

MAUDE MDR 9908917

MDR report key
9908917
Report number
3004209178-2020-92485
Event key
0
Event type
3
Date of event
2019-06-20
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
1530G INSULIN PUMP MMT-751NABARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPENDMEDTRONIC PUERTO RICO OPERATIONS CO.OZOMMT-751NABMMT-751NABA4751NABJR R

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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. PUMP RECEIVED WITH BLANK DISPLAY AND CONSTANT TONE DUE TO MOISTURE DAMAGE ON THE ELECTRONICS ASSEMBLY. UNABLE TO PERFORM ALL FUNCTIONAL TESTING INCLUDING THE OPERATING CURRENTS, A21 ERROR TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST OR VERIFY PRIME/FILL ANOMALY, REWIND ANOMALY AND EXCESSIVE NO DELIVERY ALARM DUE TO BLANK DISPLAY. PUMP RECEIVED WITH MOISTURE DAMAGE MOTOR, VIBRATOR AND BATTERY TUBE ASSEMBLY. PUMP RECEIVED WITH CRACKED BATTERY TUBE THREADS. THE P-CAP LOCKS INTO THE RESERVOIR COMPARTMENT PROPERLY NOTED. (B)(4).

D

Patient 1

INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A CRACKS IN THE BATTERY AREA, NO DELIVERY ALARM. CUSTOMER STATED THAT IT WAS LOUDER DURING REWINDING AND PRIMING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.