BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1821906 · Received August 31, 2010

    Report

    Report Number
    2939301-2010-07427
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (9/24/2012)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2010 WITH THE FOLLOWING FINDINGS: THE TEST STRIP HAS 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.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRALINK METER READ INACCURATELY ERRATIC. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON (B)(6), 2010, AT AROUND 3:00 PM. FIVE MINUTES PRIOR TO TESTING, THE PATIENT CLAIMED THAT SHE HAD DEVELOPED SYMPTOMS OF SHAKINESS, SWEATING, AND HUNGER. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "437 AND 113 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. HOWEVER, IT IS UNCLEAR AS TO WHAT DATE/TIMES THE REPORTED RESULTS WERE OBTAINED. THE PATIENT DENIED THAT SHE RECEIVED ANY TREATMENT BECAUSE OF THE ALLEGED ISSUE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT HER LAST METER READING WAS BEFORE THE SYMPTOMS DEVELOPED, WHAT DATE/TIME THE LAST READING WAS OBTAINED BEFORE THE SYMPTOMS STARTED, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS BEGAN. THE PATIENT DID NOT HAVE CONTROL SOLUTION FOR TROUBLESHOOTING. THE METER AND TEST STRIPS WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT PERFORMED A METER-TO-SAME METER COMPARISON WHERE THE CALCULATED DIFFERENCE OF THE REPORTED RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR PRECISION TESTING. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO THE PATIENT'S SYMPTOMS/INJURY. THE PATIENT CLAIMED THAT HER SYMPTOMS DEVELOPED BEFORE THE ALLEGED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1