BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3014140 · Received March 21, 2013

    Report

    Report Number
    3008382007-2013-05892
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 27, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 (12/11/2013) CORRECTION:FOR THE REPORT SUBMITTED ON 03/21/2013, THE ONETOUCH ULTRALINK METER; HOWEVER, IT SHOULD HAVE REFERENCED THE ONETOUCH PING METER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER READ INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE 7-8X DAILY AND MANAGES HIS DIABETES WITH INSULIN PUMP THERAPY. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN; HOWEVER, ON (B)(6) 2013, THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE RESULTS WHICH WERE WITHIN HIS USUAL/ EXPECTED RANGE. RESULTS WERE NOT SPECIFIED. THE PATIENT REPORTEDLY ADMINISTERED SELF HIS USUAL DOSE OF MEDICATIONS THAT DAY. LATER THAT EVENING, THE PATIENT CLAIMS HE FELT "HYPOGLYCEMIC" SYMPTOMS. SYMPTOMS WERE NOT SPECIFIED. THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "35 MG/DL" WITH THE SUBJECT METER. THE PATIENT TRIED TO DRINK ORANGE JUICE AND EAT LIFESAVER CANDIES AS TREATMENT; HOWEVER, THE PATIENT ALLEGED HE STILL "LOSS CONSCIOUSNESS". THE PATIENT'S WIFE CONTACTED EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "20 MG/DL" WITH THE EMS METER. THE PATIENT WAS ADMINISTERED A GLUCAGON INJECTION AS TREATMENT AND WAS TAKEN TO THE HOSPITAL. WHILE AT THE HOSPITAL, THE PATIENT REPORTEDLY COMPARED THE RESULTS OF THE SUBJECT METER WITH THE HOSPITAL METER. RESULTS WERE NOT SPECIFIED; HOWEVER, THE PATIENT ALLEGED THE SUBJECT METER READ "70 POINTS HIGHER" COMPARED TO THE HOSPITAL DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. QUALITY CONTROL TESTING WAS PERFORMED WHICH TESTED WITHIN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY MAY HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117665 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3369797

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R