BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3132617 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13383
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (B)(4). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 5/31/2013 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS (PA) ON (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. PA ALSO TESTED THE TEST STRIPS AND THE 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH ULTRAMINI METER WAS READING INACCURATELY COMPARED TO THE SAME METER AND COMPARED TO AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS ADDITIONAL INFORMATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT 4:20AM. THE PATIENT REPORTED READINGS OF ¿40 AND 118MG/DL¿ WERE OBTAINED ON THE LFS METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% OR <=20MG/DL WHEN OBTAINED WITHIN 20 MINUTES. THE PATIENT REPORTED USING A COMBINATION OF MEDICATIONS INCLUDING NOVOLOG, HUMALOG AND NPH INSULIN. THE PATIENT REPORTED TAKING NO MEDICATIONS IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED ON (B)(6) 2013 AT 4:20AM, A READING OF ¿52MG/DL¿ WAS OBTAINED ON AN EMS METER AND THE PATIENT HAD SOMETHING TO EAT OR DRINK AS TREATMENT AT 4:20AM. DURING THE TIME OF TROUBLESHOOTING THE CCA DETERMINED SHE WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES AND THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE REPORTER STATED, THE PATIENT¿S TESTING PROCESS WAS CORRECT AND TEST STRIP VIALS WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE THE PATIENT REQUIRED TREATMENT FROM EMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236186 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3414472

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R