BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2223323 · Received August 25, 2011

    Report

    Report Number
    2939301-2011-08101
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 [PA DATE TESTING COMPLETED] 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. 510K # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED FOR ADDITIONAL INFORMATION BY PHONE. THE PATIENT REPORTED THAT ON (B)(6) 2011 AT APPROXIMATELY 9:45AM SHE OBTAINED BLOOD GLUCOSE READINGS OF "139 MG/DL" WITH THE SUBJECT METER AND "110 MG/DL" ON TWO OTHER DEVICES (HCP"S METERS) DURING A DOCTOR'S OFFICE VISIT. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <= 30%. AT 8:43AM THAT SAME MORNING, PRIOR TO THE METER TO OTHER METER COMPARISON, THE PATIENT CLAIMED SHE TOOK AN INCREASED DOSE OF INSULIN (3.2 UNIT BOLUS) BASED ON A READING SHE HAD OBTAINED WITH SUBJECT METER (RESULT NOT PROVIDED). THE PATIENT REPORTED THAT APPROXIMATELY 45 MINUTES AFTER TAKING THE BOLUS SHE DEVELOPED SYMPTOMS OF FEELING DISORIENTED, SWEATY AND HEART RATE INCREASED. THE PATIENT CLAIMED SHE WAS TREATED WITH FOOD AND/OR DRINK BY AN HCP AT 9:45AM DURING A DOCTOR'S OFFICE VISIT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER OR TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3105195

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R