BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2872084 · Received December 13, 2012

    Report

    Report Number
    3008382007-2012-08085
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 16, 2012
    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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. 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'S RELATIVE CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER HAD DISPLAYED AN "ERROR 2" AND ALSO HAD PROMPTED AN "APPLY SAMPLE" MESSAGE AFTER A BLOOD SAMPLE HAD BEEN APPLIED TO THE TEST STRIP. THESE COMPLAINTS WERE CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO REACH THE PATIENT AND/OR REPORTER BY PHONE. THE REPORTER INFORMED THE CCA THAT BOTH ISSUES BEGAN ON (B)(6) 2012 AT 6:00AM. IT WAS NOTED THAT THE PATIENT TAKES ORAL MEDICATION TO MANAGE HIS DIABETES. THE REPORTER STATED THE PATIENT CONTINUED HIS USUAL DIABETES MANAGEMENT REGIMENT DESPITE THE ALLEGED METER MESSAGES. THE PATIENT'S RELATED REPORTED THAT AT AN UNSPECIFIED TIME AFTER THE ALLEGED METER ISSUES BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF "THIRSTY AND FREQUENT URINATION;" HOWEVER, DENIED THAT THE PATIENT RECEIVED MEDICAL TREATMENT. IT IS NOT KNOWN WHEN THE PATIENT HAD LAST TESTED WITH THE SUBJECT METER OR WHAT HIS BLOOD GLUCOSE LEVELS WERE PRIOR TO RECEIVING THE MESSAGES ON THE SUBJECT METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER DID NOT DISPLAY THE "ERROR 2" WHEN MANUALLY POWERED ON. THE CCA NOTED THAT AT THE TIME OF THE TESTS BOTH ISSUES REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THESE COMPLAINTS ARE BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUES BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3155504

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening