BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3971894 · Received July 31, 2014

    Report

    Report Number
    2939301-2014-19269
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 25, 2014
    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
    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. PT GENDER, AGE, WEIGHT: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRAMINI METER WAS GIVING INACCURATE READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2014 AT 2:30 PM THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 600 MG/DL AND 400 MG/DL ON THE REPORTED METER WITHIN 20 MINUTES. BASED ON THESE READINGS, THE PATIENT TOOK HIS USUAL DOSE OF HUMALOG INSULIN, SPECIFIC DOSE NOT PROVIDED. THIRTY MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR A DRINK; HE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGES HIS DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE EXPIRED OR STORED IMPROPERLY, WHICH CAN CAUSE INACCURATE READINGS. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT¿S TECHNIQUE WAS INCORRECT BY USING EXPIRED PRODUCT. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON ELEVATED METER READINGS, AND RECEIVED TREATMENT WITH FOOD, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446961 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3376998

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R