BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3010108 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05557
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 23, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) ALLEGING HER ONETOUCH PING METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN (B)(6) 2013; HOWEVER, THE PATIENT WAS "CONCERNED ABOUT THE PATTERN OF READINGS OVER THE LAST 3 DAYS" PRIOR TO CONTACTING LFS. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF "102 MG/DL" (OBTAINED ON DIFFERENT DAYS AND TIMES) WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATIONS. ON THE EVENING OF (B)(6) 2013, THE PATIENT REPORTED RESULTS OF "62 AND 58 MG/DL" WITH HER CONTINUOUS GLUCOSE MONITOR (CGM) AND, ON THE FOLLOWING MORNING, OBTAINED A RESULT OF "82 MG/DL" WITH HER CGM. THE PATIENT CLAIMS SHE FELT SYMPTOMS OF SWEATING, SLOW SPEECH, TIRED, HUNGRY AND WAS INCOHERENT IN CONVERSATION. THE PATIENT TOOK "LIQUID SUGAR" AS TREATMENT AND REPORTEDLY DECREASED HER USUAL INSULIN DOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. QUALITY CONTROL TESTING WAS PERFORMED WHICH TESTED WITHIN SPECIFICATIONS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113825 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3335722

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R