FDA Adverse Event Injury Summary report: N

PUMP MMT-722NAB PRDGM INS V2.2 BL EN

MDR report key: 1812028 · Received August 18, 2010

Report

Report Number
3004209178-2010-82537
Event Type
Injury
Date Received
August 18, 2010
Date of Event
June 2, 2010
Report Date
July 31, 2010
Manufacturer
MEDTRONIC PUERTO RICO OPERATIONS MED-REL
Product Code
LZG
PMA / PMN Number
P980022
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IL, 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 BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE IN THE BEGINNING OF JUNE. ATTEMPTED TO CONTACT THE CUSTOMER TWICE TO GET MORE DETAILS ABOUT THE EVENT WITHOUT ANY RESULTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PUMP MMT-722NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAB

Patients

Seq Age Sex Outcome Treatment
1 64 YR Hospitalization