FDA Adverse Event Injury Summary report: N

PUMP MMT-754CAP PRDGM INS PL

MDR report key: 1851601 · Received September 27, 2010

Report

Report Number: 3004209178-2010-82893
Event Type: Injury
Date Received: September 27, 2010
Date of Event: September 21, 2010
Report Date: September 22, 2010
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS MED-REL
Product Code: MDS
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE AND HE REQUIRED MEDICAL ATTENTION ON THREE OCCASIONS. IT WAS STATED THAT THE CUSTOMER CALLED THE PARAMEDICS TWICE, AND THE CUSTOMER WAS TAKEN TO THE HOSPITAL THE THIRD TIME. IT WAS STATED THAT THE CUSTOMER WAS HELD IN THE HOSPITAL OVERNIGHT AND RELEASED THE NEXT DAY. IT WAS STATED THAT THE CUSTOMER CONTINUED TO WEAR THE INSULIN PUMP AND HIS GLUCOSE READING WAS 9.5MMOL/L. LATER IN THE DAY, HIS BLOOD GLUCOSE DROPPED TO 2.5MMOL/L, AND THE PARAMEDICS WERE CALLED AGAIN. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 7.2MMOL/L. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP MATCHED. THE ALARM HISTORY REVEALED NO DELIVERY ALARMS. THE SETTINGS APPEARED TO BE CORRECT. THE REMAINING INSULIN IN THE RESERVOIR AND THE AMOUNT OF INSULIN ON DISPLAY APPEARED TO BE RIGHT. THE CUSTOMER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PUMP MMT-754CAP PRDGM INS PL	INFUSION PUMP	MDS	MEDTRONIC PUERTO RICO OPERATIONS MED-REL	MMT-754CAP

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization