BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2198727 · Received August 10, 2011

    Report

    Report Number
    2939301-2011-07128
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON AUGUST 2, 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PING METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE REPORTER THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2011 AT 8:30AM. THE REPORTER STATED THAT THE PATIENT MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE AND DOSAGE) AND DENIED MAKING ANY CHANGES TO THE PATIENT'S NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. A "FEW HOURS" AFTER THE ALLEGED PRODUCT ISSUE BEGAN, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF "THIRST AND FREQUENT URINATION" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE CORRECT TYPE OF TEST STRIPS WAS BEING USED AND THAT THERE WAS NO EVIDENCE OF MISUSE. THE CCA ALSO NOTED THAT THE BATTERIES DID NOT NEED TO BE REPLACED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE ALTHOUGH PRODUCT ANALYSIS (PA) TEST RESULTS CAME BACK THAT THE SUBJECT METER PASSED TESTING WITH NO FAULTS FOUND; THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2906833

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening