BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI ENHANCED METER

    MDR report key: 2243375 · Received September 12, 2011

    Report

    Report Number
    2939301-2011-08847
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 (B)(6) 2011 RESPECTIVELY, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATE HIGH AS COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE MEDICAL SURVEILLANCE SPECIALIST (MSS) FOLLOW UP CALL ON (B)(6) 2011. THE MSS WAS ADVISED BY THE PATIENT THAT SHE TESTS BETWEEN SIX TO TWELVE TIMES A DAY AND MANAGES HER DIABETES WITH THE INSULIN PUMP. THE PATIENT STATED THAT ON (B)(6) 2011 AT 7:00AM, SHE REPORTED A BLOOD GLUCOSE RESULT OF "448MG/DL" WITH A LIFESCAN METER AND "317MG/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. HALF AN HOUR LATER, THE PATIENT REPORTED INCREASING HER APIDRA DOSAGE BY 2 UNITS IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. BY 8:00AM, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF BEING "SWEATY AND DIZZY", WHICH THE PATIENT "ASSOCIATES WITH LOW BLOOD SUGAR READINGS" AND SHORTLY AFTER, SELF TREATED WITH FOOD/DRINK AND "FELT BETTER" AFTERWARDS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING BUT WAS UNABLE TO VERIFY IF THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. ALTHOUGH THE SUBJECT METER AND TEST STRIPS PASSED THE PRODUCT ANALYSIS (PA) TESTS WITH NO FAULTS FOUND, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE 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 ULTRAMINI ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3157678

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening