BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1994089 · Received February 16, 2011

    Report

    Report Number
    2939301-2011-01419
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/11/11)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K053529. 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(6) ON (B)(6) 2011 ALLEGING THAT HIS METER WAS DISPLAYING AN APPLY SAMPLE MESSAGE. HE GOT THE METER FROM HIS NURSE ON (B)(6) 2011 AND WAS NOT TOLD ON HOW TO USE THE METER. THE PATIENT MENTIONED THAT AT 3:00AM ON (B)(6) 2011, HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE AND DEVELOPED SYMPTOMS OF FEELING SWEATY AND WAS FEELING WEAK. HE THEN SELF-TREATED WITH GLUCOSE TABLETS AT AROUND 3:30AM AND FELT BETTER SOON AFTER TREATMENT. CUSTOMER CARE ADVOCATE (CCA) ASSISTED THE PATIENT AND THE ALLEGED ISSUE WAS RESOLVED OVER THE PHONE. THE PATIENT WAS USING THE INCORRECT TECHNIQUE OF APPLYING THE BLOOD ON THE TEST STRIP. THE PATIENT TESTED OVER THE PHONE AND OBTAINED A 14.2 MMOL/L (255 MG/DL) PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ISSUE HE WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH GLUCOSE TABLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3062386

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R