BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2972320 · Received February 21, 2013

    Report

    Report Number
    3008382007-2013-03404
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 26, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH PING METER DISPLAYED AN "ERROR 6" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT ON (B)(4) 2013. THE PATIENT REPORTED THAT THE ERROR MESSAGE BEGAN TO APPEAR ON THE EVENING OF (B)(6) 2013. PRIOR TO ATTEMPTING TO TEST WITH THE SUBJECT METER, THE PATIENT CLAIMED SHE HAD BEEN VOMITING AND FELT NAUSEOUS; SYMPTOMS SHE ASSOCIATED WITH A HIGH BLOOD GLUCOSE. WHEN UNABLE TO OBTAIN A READING WITH THE SUBJECT METER, THE PATIENT CONFIRMED SHE TESTED ON ANOTHER DEVICE (DOES NOT RECALL READING) AND THEN SELF-ADMINISTERED A CORRECTION BOLUS. AT THE TIME OF TROUBLESHOOTING, THE ALLEGED ERROR MESSAGE REMAINED UNRESOLVED. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE ALLEGED METER ISSUE CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT REPORTED FEELING SYMPTOMATIC PRIOR TO WHEN METER GAVE THE ERROR MESSAGE. IN ADDITION, THERE WAS NO DELAY IN TREATMENT DUE TO THE METER ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75723 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR