BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2863006 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07374
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 29, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WOULD NOT POWER ON AFTER IT HAD BEEN EXPOSED TO WATER. THE (B)(6) SURVEILLANCE (B)(6) WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2012, THE PATIENT NOTED, THE REPORTED METER WOULD NOT POWER ON AFTER IT HAD BEEN DROPPED IN WATER. THE METER OWNER'S BOOKLET WARNS THE USER AGAINST ALLOWING ANY LIQUID INTRUSION INTO THE METER. THE PATIENT NOTED, SHE DECREASED HER NOVOLOG INSULIN DOSES BY 1.0 UNIT THREE TIMES/DAY. ON (B)(6) 2012, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS TESTED BY AN HCP TO BE 182 MG/DL. ON (B)(6) 2012, THE PATIENT EXPERIENCED THE SYMPTOMS OF SWEATING AND ANXIETY, AND RECEIVED TREATMENT WITH GLUCOSE TABLETS. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THERE WAS MISUSE OF THE PRODUCT BY ALLOWING IT TO BE SUBMERGED IN WATER. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS OF SEVERE INJURY AFTER THE METER POWER ISSUE OCCURRED, AND RECEIVED TREATMENT WITH GLUCOSE, THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R