BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2895700 · Received January 3, 2013

    Report

    Report Number
    3008382007-2013-00025
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE TEST STRIP PASSED TESTING WITH NO FAULTS FOUND.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT- (B)(6) 2013: THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND AND THE COMPLAINT WAS NOT CONFIRMED. EVALUATION REVEALED A SECONDARY ISSUE IN THAT THE DISPLAY WAS DIRTY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WAS GIVING THE ERROR 2 ERROR MESSAGE WITH TEST STRIP INSERTION. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2012, AT 8:00 AM THE PATIENT OBTAINED THE ERROR MESSAGE ERROR 2 UPON INSERTION OF THE TEST STRIP IN THE REPORTED METER; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THIS METER ISSUE. TWO HOURS AFTERWARDS, THE PATIENT REPORTEDLY EXPERIENCED THE SYMPTOM OF SWEATING. THE PATIENT RECEIVED NO TREATMENT AND DID NOT SEEK MEDICAL ATTENTION. THE PATIENT DID HAVE A BACKUP METER AVAILABLE. TROUBLESHOOTING REVEALED THE TEST STRIPS WERE CORRECT, THE PATIENT'S TESTING TECHNIQUE WAS CORRECT, THERE HAD BEEN NO MISUSE OF THE PRODUCT, AND THIS WAS NOT A NEW, OUT-OF-THE-BOX, METER. THE ISSUE WAS NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER THE ERROR MESSAGE ISSUE OCCURRED ON THE REPORTED METER AND HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3295576

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening