BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2042712 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02870
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED. THE TEST STRIPS WERE REQUESTED TO BE RETURNED BUT HAVE NOT BEEN RECEIVED. EVALUATION WAS UNABLE TO CONFIRM THE ALLEGED ISSUE. THE RETURNED METER AND RETAIN TEST STRIPS ALL PASSED TESTING WITH NO FAULTS FOUND ON (B)(6) 2011, RESPECTIVELY. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY REPORTER / NURSE CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS ON THE PATIENT'S ONE TOUCH ULTRA METER. THE NURSE WAS UNABLE TO FIND THE SERIAL # OF THE METER TO PROVIDE TO THE CUSTOMER CARE ADVOCATE (CCA). THE NURSE MENTIONED THAT THE PATIENT'S METER IS READING INACCURATELY HIGH. IT IS UNKNOWN WHEN THE ALLEGED HIGH READINGS BEGAN; HOWEVER, THE PATIENT DID NOT CHANGE THEIR DIABETES REGIMEN DUE TO THE ALLEGED HIGH READINGS. THE PATIENT HAD FELT WEAK AND PALE AND TESTED THE PATIENT'S BLOOD GLUCOSE AT 8:00AM ON (B)(6) 2011 AND OBTAINED A 4.6 MMOL/L AND AT NOON OBTAINED A 5.0 MMOL/L. THE PATIENT WAS TREATED BY A NURSE WITH GLUCOSE GEL AT AN UNSPECIFIED TIME ON (B)(6) 2011. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE A NURSE ALLEGED THAT THE PATIENT HAD OBTAINED ALLEGED HIGH READINGS; HOWEVER, HAD TO RECEIVE GLUCOSE GEL FROM A NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3106800

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R