BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2810235 · Received October 31, 2012

    Report

    Report Number
    2939301-2012-12516
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 16, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE PBC CONTAMINATION AT D108 AND L102 WAS ALSO FOUND TO BE BROKEN. THE TEST STRIPS WERE ALSO RETURNED. HOWEVER, TESTING WAS NOT PERFORMED SINCE THE ALLEGED ISSUE PERTAINS TO A METER ISSUE ONLY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/ REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT (HER SON) ALLEGING HE WAS UNABLE TO TEST ON HIS ONETOUCH PING METER BECAUSE IT WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THE ALLEGED ISSUE FIRST OCCURRED 2 MONTHS PRIOR TO CONTACTING LFS. THE REPORTER STATED THE PATIENT USES INSULIN PUMP THERAPY (TYPE UNKNOWN) TO MANAGE HIS DIABETES. THE REPORTER STATED ON (B)(6) 2012, AFTER THE ALLEGED ISSUE OCCURRED, HE WENT HOME TO TEST ON HIS BACK UP OT ULTRAMINI METER AND OBTAINED A READING OF "578 MG/DL" AND ADMINISTERED INSULIN ACCORDINGLY. THE REPORTER DENIED THE PATIENT DEVELOPED ANY SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO DETERMINE THAT THE SUBJECT METER'S BATTERY DID NOT NEED TO BE REPLACED PER BATTERY USAGE LIFE RECOMMENDATIONS. THE CCA CONFIRMED THERE WAS NO MISUSE OF THE METER, AND THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. THE PATIENT WAS EDUCATED REGARDING THE METER'S AUTO SHUT OFF BEHAVIOR BUT THE ALLEGED ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT REPORTED HE WAS UNABLE TO TEST DUE TO THE ALLEGED ISSUE, HE OBTAINED A SEVERELY HIGH BLOOD GLUCOSE READING AND REQUIRED SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3292271

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R