BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2943718 · Received February 5, 2013

    Report

    Report Number
    3008382007-2013-02298
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 9, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. 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)(4) 2013, THE LAY USER/PATIENT'S MOTHER (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT HER DAUGHTER'S ONETOUCH PING METER WAS READING INACCURATELY HIGH COMPARED TO THE HOSPITAL'S METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(6) 2013, AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS BETWEEN FOUR TO SIX TIMES A DAY AND MANAGES HER DIABETES WITH NOVOLOG INSULIN (BASED ON FOOD INTAKE AND BLOOD GLUCOSE READING) VIA INSULIN PUMP. THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2012. PRIOR TO THE START OF THE ALLEGED ISSUE THE PATIENT REPORTEDLY WAS VOMITING UNCONTROLLABLY THAT DAY AND HAD GONE TO HER DOCTOR'S OFFICE. THE PATIENT'S BLOOD GLUCOSE READING PRIOR TO DOCTOR OFFICE VISIT IS NOT KNOWN; HOWEVER, ACCORDING TO THE REPORTER, THE PATIENT REPORTEDLY FELT HER BLOOD GLUCOSE READING WAS HIGH. THE REPORTER CONFIRMED THE PHYSICIAN ADVISED TAKING THE PATIENT TO THE HOSPITAL. DURING THE PATIENT TIME IN THE HOSPITAL (ON (B)(6)) THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF "260 MG/DL" WITH THE SUBJECT METER AND "161 MG" WITH THE HOSPITAL'S METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THE REPORTER CONFIRMED THE PATIENT WAS ADMINISTERED INSULIN VIA IV AS TREATMENT AND THE PATIENT WAS HOSPITALIZED OVERNIGHT DUE TO DIABETIC KETOACIDOSIS AND RELEASED THE FOLLOWING EVENING. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO EVIDENCE THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS PRIOR TO THE ALLEGED PRODUCT ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47985 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3353621

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR