BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3088792 · Received May 1, 2013

    Report

    Report Number
    3008382007-2013-09881
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 8, 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
    WY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING. THE ALLEGED ISSUE WAS NOT OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH PING METER READ INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE 4-6X DAILY AND MANAGES HIS DIABETES WITH NOVOLOG INSULIN. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2013. THE REPORTER ALLEGED THE PATIENT MAY HAVE WOKEN UP THAT MORNING NOT FEELING WELL BUT COULD NOT CONFIRM SYMPTOMS. THE PATIENT IMMEDIATELY TESTED HIS BLOOD GLUCOSE AND OBTAINED A RESULT OF "72 MG/DL" WITH THE SUBJECT METER. WHILE EATING BREAKFAST, THE REPORTER CLAIMED THE PATIENT BEGAN TO HAVE A SEIZURE AND "PASSED OUT." THE REPORTER ALLEGED THE PATIENT WOULD HAVE HAD TO HAD A BLOOD GLUCOSE "LOWER THAN 72 MG/DL" TO HAVE HAD A SEIZURE. THE PATIENT WAS ADMINISTERED A GLUCAGON INJECTION AS TREATMENT AND, WITHIN A FEW MINUTES, STARTED TO REGAIN CONSCIOUSNESS. THE REPORTER ALSO GAVE THE PATIENT JUICE TO DRINK. AFTER, A COMPARISON WAS MADE WITH THE SUBJECT METER AND ANOTHER DEVICE. THE PATIENT OBTAINED A RESULT OF "243 MG/DL" WITH THE SUBJECT METER AND "AROUND 142-146 MG/DL" WITH THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT REPORTEDLY CONTINUED TO FEEL SICK THE REST OF THE DAY WITH SYMPTOMS OF HEADACHE AND VOMITING. THE PATIENT SLOWLY STARTED TO FEEL BETTER LATER THAT EVENING. THE REPORTER COULD NOT SPECIFY RESULTS OBTAINED WITH THE SUBJECT METER THE EVENING PRIOR TO THE PATIENT'S SYMPTOMS; HOWEVER, THE REPORTER DENIED THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE. 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. 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 POSSIBLY DUE TO A DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190426 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening| R