BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2518136 · Received April 5, 2012

    Report

    Report Number
    2939301-2012-03376
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    March 17, 2012
    Report Date
    March 19, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA 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 AT AN UNSPECIFIED TIME IN MID-AFTERNOON OF (B)(6) 2012. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE AND DOSAGE), DIET, AND EXERCISE AND DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. A DAY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "HEART PALPITATIONS AND SWEAT"¿ BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THESE SYMPTOMS. THE CCA NOTED THAT THE PATIENT DID NOT HAVE TEST STRIPS AVAILABLE DURING THE TROUBLESHOOTING. 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2765348

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening