FDA Adverse Event Malfunction Summary report: N

PUMP MMT-722LNAB PRDGM INS BL EN ML

MDR report key: 1935094 · Received December 6, 2010

Report

Report Number
2032227-2010-83353
Event Type
Malfunction
Date Received
December 6, 2010
Date of Event
November 17, 2010
Report Date
November 17, 2010
Manufacturer
MEDTRONIC MINIMED
Product Code
MDS
PMA / PMN Number
P980022
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE INSULIN PUMP HAD A FROZEN SCREEN DURING THE INITIATION COUNT UP DUE TO A PROBLEM WITH THE MOTHER BOARD. UNABLE TO PERFORM FURTHER TESTING DUE TO THE FROZEN SCREEN.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE INSULIN PUMP SCREEN APPEARS TO BE CHANGING FONTS. THE CUSTOMER ALSO STATED THAT THE SCREEN FREEZES AT TIMES. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. 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 MDS MEDTRONIC MINIMED MMT-722LNAB

Patients

Seq Age Sex Outcome Treatment
1 46 YR