BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2914076 · Received January 14, 2013

    Report

    Report Number
    3008382007-2013-00762
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 19, 2012
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. UNRELATED TO THE PRIMARY ISSUE, THE BATTERY WAS FOUND EITHER LOW/DEAD UPON ARRIVAL. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WOULD DISPLAY AN HOUR GLASS AND THEN POWER OFF. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE PATIENT AND/OR REPORTER WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE HOUR GLASS APPEARING BEGAN ON THE MORNING OF (B)(6) 2012. UPON REVIEW OF THE CALL RECORDING, IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO CONTINUE TO TEST AFTER THE HOUR GLASS BEGAN TO APPEAR. IT WAS NOTED THAT THE PATIENT WAS ABLE TO SUCCESSFULLY TEST AFTER SHE RE-INSERTED THE TEST STRIP; HOWEVER, IT IS NOT KNOWN WHAT BLOOD GLUCOSE READING SHE OBTAINED. THE PATIENT INFORMED THE CCA THAT ON THE AFTERNOON OF (B)(6) /2012, A DAY PRIOR TO WHEN THE ALLEGED ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF A HEADACHE, STOMACH ACHE AND THIRSTY. IT IS NOT KNOWN IF THE PATIENT TESTED WITH THE SUBJECT METER AT ONSET OF SYMPTOMS. THE PATIENT REPORTED TREATING SELF WITH INSULIN ON (B)(6) 2012. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA, THERE IS NO EVIDENCE THAT THE ALLEGED METER ISSUE CAUSED AND/OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT WAS SYMPTOMATIC PRIOR TO WHEN THE ALLEGED ISSUE (HOUR GLASS APPEARING) BEGAN. IN ADDITION, THE PATIENT WAS ABLE TO SUCCESSFULLY TEST WITH THE SUBJECT METER WHEN SHE RE-TESTED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WITH THE HOUR GLASS APPEARING REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21375 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3337277

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR