BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2503833 · Received March 26, 2012

    Report

    Report Number
    2939301-2012-02915
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 6, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THE PATIENT'S ONETOUCH ULTRAPING METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY PATIENT THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT NOON. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH THE INSULIN PUMP AND TOOK HER USUAL DOSAGE OF NOVOLOG (UNKNOWN AMOUNT) IN RESPONSE TO THE REPORTED ISSUE. TWO HOURS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "THIRST" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOM. DURING THE TROUBLESHOOTING, THE CCA DETERMINED THAT THE SUBJECT METER WILL NOT TURN ON WITH THE INSERTION OF THE TEST STRIP. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED ISSUE OCCURRED, 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. 3190605

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening