BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2502784 · Received March 25, 2012

    Report

    Report Number
    2939301-2012-02803
    Event Type
    Injury
    Date Received
    March 25, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK 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 2:00PM. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH THE INSULIN PUMP AND ON THE SAME DAY, BETWEEN 3:30PM AND 4:00PM, TOOK HIS USUAL DOSAGE OF MEDICATIONS (UNKNOWN TYPE AND DOSAGE) IN RESPONSE TO THE REPORTED ISSUE. THREE DAYS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "HEADACHES, SWEATS AND NAUSEA" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THESE SYMPTOMS. DURING THE TROUBLESHOOTING, THE CCA NOTED THAT THERE WAS EVIDENCE OF MISUSE; THE METER GOT WET. 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 ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3210790

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening