BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2933324 · Received January 29, 2013

    Report

    Report Number
    3008382007-2013-01763
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY.A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE RETAIN TEST STRIPS ALSO PASSED TESTING. LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION BETWEEN THE PATIENT AND THE CUSTOMER SERVICE REPRESENTATIVE (CSR) BECAUSE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE MSS REVIEWED THE CALL TO OBTAIN AND VERIFY INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN BETWEEN 8 AND 9 AM ON THE SAME DAY SHE CONTACTED LFS FOR ASSISTANCE. THE PATIENT REPORTED THAT SHE WOKE UP FEELING 'FOGGY AND INCOHERENT.' AFTER SHOWERING, SHE TESTED WITH THE SUBJECT METER AND OBSERVED A VALUE OF '65MG/DL.' THE PATIENT MANAGES HER DIABETES WITH AN UNKNOWN TYPE/DOSE OF INSULIN THROUGH PUMP THERAPY AND DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. SOMETIME AFTER 9AM SHE SELF-TREATED HER SYMPTOMS WITH ORANGE JUICE AND A HARD CANDY. SHE REPORTED THAT A FAMILY MEMBER HAD CONTACTED EMERGENCY MEDICAL SERVICES (EMS) DUE TO HER NOT ANSWERING THE PHONE. WHEN THE PARAMEDICS ARRIVED BETWEEN 9:30-10AM THE PATIENT WAS 'STRUGGLING TO WALK TO THE DOOR AND WAS INCOHERENT.' THE EMS RESPONDER TESTED THE PATIENT USING AN UNKNOWN EMS METER AND OBSERVED A VALUE OF '47MG/DL.' THE PATIENT ATE BREAD WITH PEANUT BUTTER AFTER THIS READING AND THE EMS TESTED HER AGAIN, BOTH WITH THEIR DEVICE AND THE SUBJECT METER AND OBSERVED RESULTS OF '58MG/DL' AND '80MG/DL' RESPECTIVELY. NO OTHER FORM OF TREATMENT WAS ADMINISTERED. IT IS UNKNOWN WHAT THE PATIENT'S PREVIOUS BLOOD GLUCOSE RESULTS WERE PRIOR TO HER DEVELOPING THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE.REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. ALTHOUGH THE PATIENT WAS SYMPTOMATIC PRIOR TO TESTING ON THE SUBJECT DEVICE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DELAYED TREATMENT OF HER SYMPTOMS DUE TO THE ALLEGED METER READING. WHEN HER BLOOD GLUCOSE WAS TESTED ON THE EMS METER, THE RESULT OBTAINED WAS SUGGESTIVE THAT SHE WAS SEVERELY HYPOGLYCEMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39646 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3350376

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR