BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4000938 · Received August 12, 2014

    Report

    Report Number
    2939301-2014-20512
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 5, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/08/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 8/18/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/20/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IN ADDITION, A SECONDARY ISSUE WAS NOTED WHEN THE METER WAS FOUND TO HAVE A DEFECTIVE PROCESSOR CPU U5. 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONE TOUCH ULTRAMINI METER WOULD NOT POWER OFF. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN ON (B)(6) 2014 AT 10:00 A. M. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (UNKNOWN TYPE, SELF-ADJUSTER). AT 1:00 P. M. THE PATIENT MENTIONED HE HAD MORE FOOD/DRINK IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT STATED, 4 HOURS AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS OF ¿LOW BLOOD SUGAR.¿ THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THIS WAS NOT THE FIRST TIME THE PATIENT USED THE METER AND THERE WAS NO MISUSE OF THE PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480793 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3602960

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening