BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2900718 · Received January 8, 2013

    Report

    Report Number
    3008382007-2013-00264
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 17, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. UNRELATED TO THE ISSUE, THE BATTERY THAT WAS RETURN WAS FOUND DEAD. THE ERROR COULD NOT BE REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER WAS NOT POWERING WHEN ON SHE TRIED TO TEST HER BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2012 AT 10 AM. THE PATIENT DENIED USING ANY MEDICATIONS TO MANAGE HER DIABETES. THE PATIENT REPORTED DUE TO THE ALLEGED ISSUE SHE HAD LESS TO EAT OR DRINK THAN USUAL. THE PATIENT REPORTED 30-60 MINUTES LATER, SHE HAD SYMPTOMS OF "SWEATING, COLD, CLAMMY AND HEADACHE". THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION IN RESPONSE TO HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THERE WAS NO MISUSE OF THE METER AND THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. WHEN THE SUBJECT TEST STRIP WAS INSERTED, THE METER DID NOT TURN ON. WHEN THE POWER BUTTON WAS PRESSED, THE METER DID TURN ON. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE REPORTER CLAIMS, DUE TO THE ALLEGED ISSUE THE PATIENT HAD LESS TO EAT OR DRINK THAN USUAL AND DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8724 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3370238

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening