BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2962919 · Received February 15, 2013

    Report

    Report Number
    3008382007-2013-03082
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    February 9, 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 (03/26/2013)-DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2013 AND (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING AND FUNCTIONED PROPERLY; NO FAULTS WERE FOUND. THE TEST STRIPS ALSO PASSED TESTING WITH NO FAULTS FOUND. 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 HIS ONETOUCH ULTRAMINI METER DISPLAYED AN UNKNOWN "ERROR" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ABOUT A MONTH PRIOR TO CONTACTING LFS. THE PATIENT DOES NOT TAKE MEDICATIONS TO MANAGE HIS DIABETES; HOWEVER, IN (B)(6) (YEAR NOT SPECIFIED), THE PATIENT REPORTEDLY EXERCISED. AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS HE HAD SYMPTOMS OF DRY MOUTH AND BLURRED VISION. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND 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
    68620 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3218934

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening