BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2105853 · Received May 27, 2011

    Report

    Report Number
    2939301-2011-04461
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 26, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K061118. 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 ON (B)(6) 2011 ALLEGING A FADING DISPLAY ON HIS ONE TOUCH ULTRAMINI METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION : THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN ON (B)(6) 2011 AT AROUND 1:00PM. DUE TO THE ALLEGED ISSUE, THE PATIENT TOOK 8 UNITS OF INSULIN. APPROXIMATELY 4-5 HOURS AFTER TAKING THE INSULIN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SWEATY, SHIVERS AND HAD THE SHAKES. THE PATIENT IMMEDIATELY SELF-TREATED; HOWEVER, IT IS UNCLEAR WHAT HE TREATED HIMSELF WITH. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. BASED ON THE INITIAL CALL, THERE WAS NOT MISUSE OF THE PRODUCT. THE METER WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R