BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3200825 · Received July 2, 2013

    Report

    Report Number
    3008382007-2013-18840
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/19/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/6/2013 AND 9/11/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 07/26/2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT AN UNKNOWN TIME. SHE TESTED ON THE SUBJECT METER AND OBSERVED A VALUE OF ¿179MG/DL¿ AS COMPARED TO A READING ON A HOSPITAL METER WHICH GAVE A READING OF ¿114MG/DL¿ PERFORMED GREATER THAN 30 MINUTES EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH METFORMIN PILLS AND CONTINUED WITH HER NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT IMMEDIATELY AFTER THE ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿BLURRED VISION.¿ SHE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE. THE TIME DIFFERENCE BETWEEN THE 2 TESTS WAS GREATER THAN 30 MINUTES. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303323 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3433230

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening