FDA Adverse Event Injury Summary report: N

PUMP MMT-722LNAB PRDGM INS BL EN ML

MDR report key: 1052828 · Received May 27, 2008

Report

Report Number
2032227-2008-00889
Event Type
Injury
Date Received
May 27, 2008
Date of Event
May 12, 2008
Report Date
May 13, 2008
Manufacturer
MEDTRONIC MINIMED
Product Code
LZG
PMA / PMN Number
P980022
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
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

THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. NO BLOOD GLUCOSE READING WAS REPORTED. THE CUSTOMER'S MOTHER ALSO STATED THAT CUSTOMER WAS GETTING NO DELIVERY ALARMS PRIOR TO THE HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PUMP MMT-722LNAB PRDGM INS BL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAB

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization