BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3971918 · Received July 31, 2014

    Report

    Report Number
    2939301-2014-19271
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 25, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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/REPORTER CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRA2 METER WAS GIVING THE ¿APPLY SAMPLE¿ ICON DURING TESTING. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2014 THE PATIENT OBTAINED THE ¿APPLY SAMPLE¿ ICON ON THE REPORTED METER DURING TESTING; HE DID NOT OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THIS METER ISSUE. THE PATIENT MANAGES HIS DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. ONE DAY AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND LIGHTHEADEDNESS; HE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE CORRECT AND CORRECTLY DREW IN THE BLOOD SAMPLE AND THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT. THE ISSUE WAS NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL DUE TO THE METER ISSUE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446503 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3623084

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening