FDA Adverse Event Injury Summary report: N

PUMP MMT-723NAP PRDGM INSULIN PURPLE EN

MDR report key: 1842885 · Received September 17, 2010

Report

Report Number: 3004209178-2010-82853
Event Type: Injury
Date Received: September 17, 2010
Date of Event: September 3, 2010
Report Date: September 3, 2010
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS MED-REL
Product Code: MDS
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CURRENTLY, IT IS UNK 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

THE CUSTOMER REPORTED THAT SHE CHANGED THE RESERVOIR AND THE INFUSION SET, AND SHORTLY AFTER SHE NOTICED THAT THE RESERVOIR WAS COMPLETELY EMPTY. THE CUSTOMER'S BLOOD GLUCOSE WAS 180MG/DL AT TIME OF THE CALL, AND IT DROPPED TO 126MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PRIME HISTORY WAS REVIEWED AND FOUND THAT THE RESERVOIR FILL PROCESS WAS NOT EVEN COMPLETED, BUT THE CUSTOMER CHANGED THE RESERVOIR AND THE INFUSION SET. THE CUSTOMER STATED THAT SHE DID NOT RECALL REWINDING THE DEVICE AFTER FILLING THE RESERVOIR. ADVISED THE CUSTOMER SINCE THE RESERVOIR WAS EMPTIED AND IT WAS UNK WHETHER OR NOT THE FULL 300 UNITS WAS DELIVERED, MEDICAL ASSISTANCE IS NEEDED. THE CUSTOMER STATED THAT SHE HAD CONTACTED HER DOCTOR. DURING A FOLLOW UP CALL WITH THE CUSTOMER IT WAS FOUND THAT SHE ENDED UP IN THE EMERGENCY ROOM. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PUMP MMT-723NAP PRDGM INSULIN PURPLE EN	INFUSION PUMP	MDS	MEDTRONIC PUERTO RICO OPERATIONS MED-REL	MMT-723NAP

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Hospitalization