BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1896772 · Received November 10, 2010

    Report

    Report Number
    2939301-2010-09784
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 25, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ALLEGING THAT THE CASING ON HIS METER WAS CRACKED/BROKEN. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE FOLLOWING IS BASED ON THE INITIAL CALL: THE PATIENT MENTIONED THAT THE ENTIRE CASING OF THE METER WAS STOMPED ON, THE NIGHT OF (B)(6) 2010. THE PATIENT WAS UNABLE TO TEST AND DID NOT TAKE ANY ACTION AFTER THE ALLEGED ISSUE BEGAN. APPROXIMATELY 3 DAYS LATER, THE PATIENT EXPERIENCED FREQUENT URINATION DRY SKIN AND DRY MOUTH. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN DUE TO THE ALLEGED ISSUE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE PRODUCT WAS REPLACED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, READINGS PRIOR TO THE EVENT, WHETHER THE PATIENT CONTINUED TO TAKE HIS DIABETES REGIMEN AND HOW LONG SYMPTOMS LASTED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE CRACKED CASING OF THE METER, HE WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening