BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2638777 · Received July 3, 2012

    Report

    Report Number
    2939301-2012-07384
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Report Date
    June 26, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY ERRATIC WHEN PERFORMING BACK TO BACK BLOOD GLUCOSE TESTS. THIS COMPLAINT WAS CLASSIFIED BASED ON THE INFORMATION OBTAINED BY THE CUSTOMER CARE ADVOCATE (CCA). THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN AROUND 11:15 A.M. ON (B)(6) 2012, THE PATIENT CLAIMED THAT SHE OBTAINED BACK TO BACK BLOOD GLUCOSE RESULTS OF "83, 143, 163, AND 173 MG/DL" WITH THE SUBJECT METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT MENTIONED THAT A COUPLE OF MINUTES PRIOR TO OBTAINING THE ALLEGED INACCURATE ERRATIC RESULTS SHE HAD TRIED TO CONTACT HER DOCTOR BECAUSE FELT "SHAKY AND SWEATY" WHICH SHE ASSOCIATE WITH FEELING LOW, BUT WAS PLACED ON HOLD. THE PATIENT INFORMED THAT CCA THAT THE SAME ISSUE HAS HAPPENED MORE THAN ONCE, BUT SHE WAS UNABLE TO PROVIDE SPECIFIC DETAILS. THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES. AT THE TIME OF TROUBLESHOOTING THE PATIENT DID NOT HAVE CONTROL SOLUTION. THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND THAT THE PATIENT WAS USING AN APPROVED SAMPLE SITE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING AND REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING RULED OUT AS AN ADVERSE EVENT BECAUSE THE REPORTED SYMPTOMS STARTED PRIOR TO THE PATIENT OBTAINING THE INACCURATE ERRATIC RESULTS. IN ADDITION, THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3266382

    Patients

    Seq Age Sex Outcome Treatment
    1