BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2211049 · Received August 14, 2011

    Report

    Report Number
    2939301-2011-07353
    Event Type
    Injury
    Date Received
    August 14, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE 510(K) # 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 WAS READING INACCURATELY HIGH AS COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT ON (B)(6) 2011 AT 4:45PM, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "249, 136 AND 294MG/DL" WITH A LIFESCAN METER AND "209, 109, AND 40MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OR LESS OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDED THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH THE INSULIN PUMP AND A MINUTE AFTER THE ALLEGED ISSUE OCCURRED, INCREASED HER HUMALOG INTAKE TO "7.5 UNITS, 34 CARBS." FORTY-FIVE MINUTES AFTER THE REPORTED ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE "BLACKED OUT." BY 5:45PM ON THE SAME DAY, EMS WAS CALLED IN WHO TESTED THE PATIENT'S BLOOD GLUCOSE ON THEIR METER AND OBTAINED A RESULT OF "43MG/DL." THE PATIENT WAS SHORTLY GIVEN GLUCOSE TABLETS/GLUCOSE GEL. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT STATED SHE DEVELOPED SYMPTOMS OF A SERIOUS INJURY AND RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED PRODUCT ISSUE OCCURRED.

    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 54 YR Life Threatening