BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3102969 · Received May 9, 2013

    Report

    Report Number
    3008382007-2013-10776
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 14, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 497 MG/DL AND "HI MG/DL" (GREATER THAN 600 MG/DL) ON THE REPORTED METER. THE PATIENT TOOK HIS USUAL DOSE OF INSULIN. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING, IMPAIRED VISION AND FORGETFULNESS. THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE HE RECEIVED TREATMENT WITH INSULIN. THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE LEVEL WAS NOT RETESTED WHILE IN THE ER. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. ALTHOUGH THE TREATMENT RECEIVED IN THE EMERGENCY ROOM CORRELATED WITH THE PATIENT'S METER READINGS, THIS COMPLAINT IS BEING REPORTED AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING ELEVATED READINGS ON THE REPORTED METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203967 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3420946

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening