BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3971907 · Received July 31, 2014

    Report

    Report Number
    2939301-2014-19270
    Event Type
    Injury
    Date Received
    July 31, 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
    MA, 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRAMINI METER WAS GIVING THE ERROR 2 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE IN (B)(6) 2014 THE PATIENT OBTAINED THE ERROR MESSAGE ERROR 2 ON THE REPORTED METER DURING TESTING; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THIS METER ISSUE. THE PATIENT MANAGES HER DIABETES WITH SET DOSES OF INSULIN. AFTER THE ATTEMPTED USE OF THE METER, THE PATIENT EXPERIENCED THE SYMPTOMS OF BEING TIRED, FATIGUE AND SHE FELT HYPOGLYCEMIC. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR A DRINK; SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT¿S TECHNIQUE OF APPLYING THE BLOOD SAMPLE TO THE TEST STRIP WAS INCORRECT, WHICH CAN CAUSE THE RESULTANT ERROR MESSAGE. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING AND PATIENT EDUCATION. THE PATIENT¿S TESTING TECHNIQUE WAS INCORRECT WHICH CAN CAUSE ERROR MESSAGES TO BE DISPLAYED. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER THE METER ISSUE OCCURRED, AND RECEIVED TREATMENT WITH FOOD, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446478 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3443126

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R