BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2416932 · Received January 16, 2012

    Report

    Report Number
    2939301-2012-00571
    Event Type
    Injury
    Date Received
    January 16, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    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. (B)(4). 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 10PM. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HIS DIABETES WITH INSULIN (VIA INSULIN PUMP); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED POWER ISSUE. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF SHAKING AND CLAMMY EIGHT HOURS LATER. THE PATIENT, HOWEVER, DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION/TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THERE WAS MISUSE OF THE PRODUCT. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. ALTHOUGH IT WAS DISCOVERED THAT THE SUBJECT METER WAS MISUSED BY THE PATIENT, THEREFORE RESULTING IN THE REPORTED POWER ISSUE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED POWER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3149926

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening