BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1832556 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07802
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    510 (K) # IS K061118.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

    MANUFACTURER'S INVESTIGATIONAL UNIT CONFIRMED A MELTED APPEARANCE ON THE SCREEN OF THE PERFORMA METER. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6), 2010 ALLEGING AN ERROR 5 MESSAGE ON HIS ONE TOUCH ULTRAMINI METER. THE PATIENT MENTIONED HE FIRST OBTAINED THE ERROR 5 MESSAGE AT 9:15PM ON (B)(6), 2010. THE PATIENT DID NOT TAKE ANY ACTION AFTER HE OBTAINED THE ALLEGED ERROR 5 MESSAGE. APPROXIMATELY 10 MINUTES LATER, HE DEVELOPED SYMPTOMS OF COLD SWEATS, WEAK AND FEELING SHAKY. HE SELF-TREATED WITH FOOD AND /DRINK AT 9:30PM AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIP DID NOT COMPLETELY DRAW IN THE SAMPLE OF BLOOD. CUSTOMER CARE ADVOCATE (CCA) HAD THE PATIENT RETEST AND THE ISSUE WAS NOT RESOLVED. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERROR 5 MESSAGE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3011071

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R