BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 3802477 · Received May 9, 2014

    Report

    Report Number
    2939301-2014-10777
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    May 2, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRASMART METER DISPLAY WAS FROZEN ON THE CALIBRATION CODE NUMBER. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2014 AT 9:00 AM, THE PATIENT NOTED THE REPORTED METER¿S DISPLAY WAS FROZEN ON THE CALIBRATION CODE NUMBER 25 AND SHE WAS UNABLE TO PERFORM A BLOOD GLUCOSE TEST. THE PATIENT MANAGES HER DIABETES WITH NOVOLOG INSULIN TAKEN ON A SLIDING SCALE AND 20.0 UNITS LANTUS INSULIN. AFTER THE ATTEMPTED USE OF THE METER, THE PATIENT TOOK THE ACTION OF TAKING HER 20.0 UNITS LANTUS INSULIN BUT DID NOT TAKE ANY NOVOLOG INSULIN. AT AN UNSPECIFIED TIME AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING AND SHE FELT HYPOGLYCEMIC. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN WITHOUT BENEFIT OF A BLOOD GLUCOSE READING DUE TO THE METER DISPLAY ISSUE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281308 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3447403

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening