BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3212136 · Received July 9, 2013

    Report

    Report Number
    3008382007-2013-19103
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    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) 2013, THE LAY USER/PATIENT¿S WIFE (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO THE PATIENT¿S FEELING/ NORMAL RESULT(S). THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2013 (BETWEEN 8:30PM-9PM). THE PATIENT REPORTEDLY HAD OBTAINED A BLOOD GLUCOSE READING OF ¿292 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER) AND IN RESPONSE TO THE REPORTED RESULT THE PATIENT REPORTEDLY ADMINISTERED HIS USUAL DOSE OF MEDICATION (6 UNITS NOVOLIN R, 10 UNITS NOVOLIN N) SOON AFTERWARDS. ACCORDING TO THE CSR¿S DOCUMENTATION, AS A RESULT OF THE ALLEGED ISSUE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM (ASSOCIATED WITH LOW BLOOD GLUCOSE) OF SWEATING APPROXIMATELY AT 4AM (ON (B)(6)) AND WAS ADMINISTERED TREATMENT (BY THE REPORTER) OF FOOD AND/OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313419 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3395700

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R