BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2413737 · Received January 12, 2012

    Report

    Report Number
    2939301-2012-00505
    Event Type
    Injury
    Date Received
    January 12, 2012
    Report Date
    January 5, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    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. THE 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAPING METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE AND TIME AT THE END OF (B)(6) 2011. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH THE INSULIN PUMP AND DENIED MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. AT AN UNKNOWN DATE AND TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT STATED THAT SHE DEVELOPED SYMPTOMS OF "DRY MOUTH, FREQUENT URINATION AND THIRST" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THESE SYMPTOMS. DURING TROUBLESHOOTING, THE CCA DETERMINED THAT THE BATTERIES NEEDED REPLACEMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED ISSUE BEGAN, THIS COMPLAINT IS BEING REPORTED BECAUSE 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. 3162683

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening