BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3243994 · Received July 24, 2013

    Report

    Report Number
    3008382007-2013-20827
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Report Date
    July 12, 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
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THAT HIS ONETOUCH PING METER REMOTE DID NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT DID NOT RECALL WHEN THE ALLEGED POWER ISSUE STARTED. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (ON INSULIN PUMP THERAPY). THE PATIENT INFORMED THE CCA THAT HE TOOK AN INCREASED DOSE OF INSULIN (1 UNIT PER CARBOHYDRATE) ON AN UNSPECIFIED DATE TO THE METER ISSUE. THE PATIENT ALSO REPORTED DEVELOPING SYMPTOMS OF ¿FATIGUE, HEADACHES AND SICK TO STOMACH¿ A COUPLE OF MONTHS AFTER POWER ISSUE STARTED; HOWEVER, DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER¿S BATTERY DID NOT NEED TO BE REPLACED PER THE OWNER¿S BOOKLET RECOMMENDATION. THE SUBJECT METER DID NOT POWER ON MANUALLY WHEN A METER BUTTON WAS PRESSED. THE PATIENT DID NOT HAVE TEST STRIPS TO CONFIRM WHETHER OR NOT THE SUBJECT METER WOULD POWER ON WHEN A STRIPS WAS INSERTED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S REPORTED SYMPTOMS DO NOT MEET LFS CRITERIA OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345762 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR