BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3011533 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05443
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 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
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED TO LIFESCAN; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (04/22/2013)-DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING AND FUNCTIONED PROPERLY; NO FAULTS WERE FOUND. THE TEST STRIPS ALSO PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PING METER HAD POWERED OFF DURING USE AND NO LONGER POWERED ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S MOTHER REPORTED THAT THE ALLEGED POWER ISSUES STARTED ON (B)(6) 2013 BETWEEN 6:30PM AND 7:30PM. THE REPORTER INFORMED THE CCA THAT THE PATIENT IS ON INSULIN PUMP THERAPY. THE CCA NOTED THAT THE REPORTER DENIED THAT THE PATIENT TOOK ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED POWER ISSUES. HOWEVER, THE PATIENT'S MOTHER REPORTED THAT APPROXIMATELY ½ HOUR AFTER THE METER POWER ISSUES STARTED HE DEVELOPED SYMPTOMS OF "WEAK AND SHAKY". THE REPORTER CLAIMED THE PATIENT TREATED HIMSELF WITH FOOD AND/OR DRINK SHORTLY AFTER THE ONSET OF SYMPTOMS. AT THE TIME OF THE CALL, THE PATIENT INFORMED THE CCA THAT THE PATIENT WAS TESTED WITH A DIFFERENT DEVICE (FREESTYLE) AND OBTAINED A READING OF "89 MG/DL" SOMETIME BETWEEN 6:30 AND 7:30PM. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE REPORTER CONFIRMED THAT THE SUBJECT METER POWERING ON BOTH MANUALLY AND WHEN A TEST STRIP WAS INSERTED AFTER THE METER'S BATTERIES HAD BEEN REPLACED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113645 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3388025

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR