BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3011317 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05584
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE ERROR COULD NOT BE REPRODUCED. THE TEST STRIPS WERE FOUND TO HAVE A VIAL WHICH WAS EXPOSED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: METER- (B)(4) 2013, TEST STRIPS- (B)(4) 2013. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING FOR ALL CONTROL SOLUTION LEVEL EXCEPT FOR LEVEL 2. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT ON (B)(6) 2013 SHE OBTAINED BLOOD GLUCOSE READINGS OF "238 MG/DL" WITH THE SUBJECT METER AND "108 MG/DL" ON A LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20%. THE PATIENT IS ON INSULIN PUMP THERAPY. THE PATIENT INFORMED THE CCA THAT A COUPLE OF WEEK PRIOR TO WHEN THE METER TO LAB COMPARISON WAS PERFORMED SHE TOOK AN INCREASED DOSE OF INSULIN BASED ON A RESULT OBTAINED WITH THE SUBJECT METER. IT IS NOT KNOWN WHAT VALUE THE PATIENT OBTAINED. THE PATIENT CLAIMED THAT AFTER TAKING THE INCREASE DOSE OF MEDICATION SHE DEVELOPED SYMPTOMS OF SHAKY AND CONFUSION AND SELF-TREATED WITH FOOD AND/OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE. THE CCA ALSO VERIFIED THAT THE TEST STRIPS WERE NOT EXPIRED OR OPEN PAST THEIR DISCARD DATE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114599 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3217900

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R