FDA.reportPublic FDA data

MAUDE MDR 9908840

MDR report key
9908840
Report number
3004209178-2020-92447
Event key
0
Event type
3
Date of event
2019-06-21
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-751LNASARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPENDMEDTRONIC PUERTO RICO OPERATIONS CO.OZOMMT-751LNASMMT-751LNASA6751LNASJ* 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

THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP ALARMED UNEXPECTED RESTART. CUSTOMER DID NOT RECALL BLOOD GLUCOSE AT THE TIME OF INCIDENT. TROUBLESHOOTING FOR THE ALARM WAS PARTIALLY PERFORMED. THE CUSTOMER SAID THE ALARM REOCCURRED AFTER CHANGING BATTERY IN THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.