BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3946033 · Received July 21, 2014

    Report

    Report Number
    2939301-2014-17990
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    July 11, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON 07/25/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 07/29/2014 WITH THE FOLLOWING FINDINGS: THE METER HAS 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) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT SHE TESTING IN THE MEMORY MODE, USE ERROR ISSUE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CA) DOCUMENTATION. THE REPORTED ISSUE BEGAN ON (B)(6) 2014 AT 9 AM. THE PATIENT CLAIMED THAT DUE TO THE TESTING IN THE MEMORY MODE ISSUE, SHE DEVELOPED SYMPTOMS DESCRIBED AS ¿SHAKY.¿ THE PATIENT DID NOT BASE HER DIABETES MANAGEMENT ON THE SUBJECT METER AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. DURING TROUBLESHOOTING, THE ISSUE WAS RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED DUE TO A POSSIBLE USE ERROR AND BECAUSE THE PATIENT HAD SYMPTOM THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER SHE ENCOUNTERED THE TESTING IN MEMORY MODE ISSUE. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425318 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3640810

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening