BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3871023 · Received June 13, 2014

    Report

    Report Number
    2939301-2014-14356
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    June 4, 2014
    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
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/07/2014). DEVICE EVALUATION -THE LAY USER/PATIENT¿S METER AND STRIPS HAVE BEEN RETURNED ON 06/26/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 06/27/2014 WITH THE FOLLOWING FINDINGS:ERROR MESSAGE IS OBSERVED IN THE ERROR LOG, BUT ERROR WAS NOT REPRODUCED DURING THE INVESTIGATION. 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) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER READ INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ABOUT 7 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿20-30 POINTS DIFFERENCE¿ BETWEEN ANOTHER TEST STRIP LOT NUMBER (LOT NUMBER 3495264) AND DEVICE; HOWEVER, SPECIFIC RESULTS WERE NOT PROVIDED. THE PATIENT MANAGES HIS DIABETES WITH ACTOS PILLS, METFORMIN PILLS AND LANTUS INSULIN. ABOUT 5 WEEKS PRIOR TO CONTACTING LFS, THE PATIENT REPORTEDLY INCREASED HER USUAL DOSE OF LANTUS INSULIN (AMOUNT NOT SPECIFIED). AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF HEADACHE, DIZZINESS, NAUSEOUS, LETHARGIC AND SHAKY. TREATMENT WAS NOT SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. 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
    350808 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3475723

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Life Threatening