BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3231317 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-20147
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 25, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (08/22/2013). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 8/7/2013 AND 8/14/2013, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/14/2013 AND 8/19/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, BETWEEN 2-2:30PM. THE PATIENT CLAIMED SHE WAS AT THE DOCTOR¿S OFFICE AND APPROXIMATELY 20 MINUTES PRIOR TO THE ALLEGED ISSUE SHE WAS EXPERIENCING SYMPTOMS OF ¿SHAKING.¿ THE PATIENT TESTED ON THE SUBJECT METER AND OBSERVED A VALUE OF ¿289MG/DL¿ AND WITHIN 30 MINUTES SHE TESTED WITH THE DOCTOR¿S METER (ONETOUCH ULTRAMINI) AND OBSERVED A VALUE OF ¿89MG/DL¿ WHICH SHE FELT CORRELATED WITH HER SYMPTOMS. THE PATIENT REPORTED THAT SHE SELF TREATED BY EATING A PIECE OF CANDY AND FELT BETTER IMMEDIATELY AFTERWARDS. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT MANAGES HER DIABETES WITH NOVOLOG INSULIN THROUGH PUMP THERAPY AND DID NOT TAKE ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT COULD NOT RECALL WHAT HER EARLIER LUNCH TIME READING WAS. 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. THE SUBJECT TEST STRIPS WERE UNEXPIRED AND STORED CORRECTLY. 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. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF TREATMENT DUE TO THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ CRITERIA FOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331597 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3336964

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR