BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2060375 · Received April 15, 2011

    Report

    Report Number
    2939301-2011-03139
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH MINI METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6) 2011 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HIS TESTING FREQUENCY IS 4 TIMES DAILY AND MANAGES HIS DIABETES WITH HUMALOG (16 UNITS, 3X DAILY) AND LEVEMIR (66 UNITS, BEFORE BEDTIME) INSULIN. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 6:00PM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "192, 232, 229, 171, AND 193 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. DESPITE THE ALLEGED ISSUE THE PATIENT CONFIRMED HE DID NOT TAKE ANY ACTION REGARDING HIS DIABETES REGIMEN. APPROXIMATELY 10 MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CONFIRMED HE BECAME WEAK AND CLAMMY; WHICH HE ASSOCIATED AS LOW BLOOD SUGAR SYMPTOMS. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLARIFIED AND CONFIRMED HE DRANK 2 GLASSES OF REGULAR (B)(6) AND WITHIN 10 MINUTES LATER HE FELT BETTER. AT THE TIME THE ALLEGED ISSUE BEGAN, THE PATIENT CONFIRMED NO OTHER BLOOD GLUCOSE DEVICE WAS USED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT AND THE RESULTS OBTAINED WERE FROM THE SAME APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CONFIRMED HE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER 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 ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3108423

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R