FDA.reportPublic FDA data

MAUDE MDR 9908905

MDR report key
9908905
Report number
3004209178-2020-92481
Event key
0
Event type
3
Date of event
2020-03-19
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
12020-03-3101. H

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. (B)(4).

D

Patient 1

THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE AND WAS TAKEN TO EMERGENCY MEDICAL SERVICES CENTER. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WOULD NOT DELIVER INSULIN CONSISTENTLY, REWIND SLOWLY AND INSULIN SQUIRTS DURING PRIME. THE CUSTOMER'S BLOOD GLUCOSE HAD BLOOD GLUCOSE OVER 200 MG/DL AFTER GETTING TREATMENT. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.