BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2222673 · Received August 25, 2011

    Report

    Report Number
    2939301-2011-08050
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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'S RELATIVE CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE HIGH ISSUE WITH THE PATIENT'S ONE TOUCH ULTRAMINI METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED TIME OF THE MORNING ON (B)(6) 2011. THE PATIENT OBTAINED A RESULT OF "92 MG/DL" ON THE SUBJECT METER, AND "21 MG/DL" ON ANOTHER METER, DONE LESS THAN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IT IS UNKNOWN WHAT TYPES OF RESULTS WERE OBTAINED ON THE SUBJECT METER BEFORE THE ISSUE STARTED. REPORTEDLY THE PATIENT'S REPORTER WOKE TO THE PATIENT BEING INCOHERENT AND TESTED HER GLUCOSE WITH THE SUBJECT METER. HE CLAIMED HE OBTAINED A RESULT OF "92 MG/DL" AND IMMEDIATELY CONTACTED EMERGENCY MEDICAL SERVICES (EMS). THE REPORTER STATED THAT THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF METFORMIN, LANTUS AND HUMULIN AND DUE TO THE ALLEGED ISSUE DENIED MAKING ANY CHANGES TO HER USUAL TREATMENT. THE REPORTER STATED EMS ARRIVED 20 MINUTES AFTER PLACING THE CALL TESTED THE PATIENT'S GLUCOSE WITH THEIR EMS METER, A RESULT OF "21 MG/DL" WAS OBTAINED AND THEY TREATED THE PATIENT WITH IV GLUCOSE. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE SET IN THE METER AND WAS USING AN APPROPRIATE SAMPLE SITE. HOWEVER, THE AGENT ALSO NOTED THAT THE METER WAS CODED INCORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3062929

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R