BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3181154 · Received June 21, 2013

    Report

    Report Number
    3008382007-2013-17924
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 27, 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
    WV, 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 (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2013. THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DOSE OF MEDICATIONS; HOWEVER, ON (B)(6)2013, THE PATIENT REPORTEDLY TOOK MORE FOOD AND/OR DRINK. ON THE AFTERNOON OF (B)(6) 2013, THE PATIENT CLAIMED SHE FELT A SYMPTOM OF DIZZY, BLURRED VISION, HEADACHE AND NAUSEA. TREATMENT WAS NOT SPECIFIED AT THAT TIME; HOWEVER, ON (B)(6) 2013, THE PATIENT REPORTEDLY VISITED THE EMERGENCY ROOM (ER) AND OBTAINED BLOOD GLUCOSE A BLOOD GLUCOSE RESULT OF ¿OVER 500 MG/DL¿ WITH ANOTHER METER AND A LABORATORY DEVICE. THE PATIENT WAS ADMINISTERED NOVOLOG INSULIN (6 UNITS TO 12 UNITS) AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT TEST STRIPS WERE BEING USED AND THERE WAS NO INDICATION OF MISUSE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282163 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3051714

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R