BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2841297 · Received November 21, 2012

    Report

    Report Number
    3008382007-2012-06570
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 29, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING BLACK MARKS ON THE DISPLAY OF HIS ONETOUCH ULTRASMART METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE WAS DISCOVERED ON (B)(6) 2012 (BETWEEN 6-6:30PM). THE PATIENT DENIED TESTING HIS BLOOD GLUCOSE WITH ANOTHER DEVICE AFTER THE ALLEGED DISPLAY ISSUE OCCURRED. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK IN RESPONSE TO THE REPORTED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, "RIGHT AFTER" THE ALLEGED METER ISSUE WAS DISCOVERED, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKING AND FELT FAINT. THE PATIENT REPORTEDLY CONSUMED (AT 7:30PM) FOOD AND/OR DRINK AS SELF-TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3350814

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R