BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT LANCETS

    MDR report key: 1930895 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10809
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    December 5, 2010
    Report Date
    December 6, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    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

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING A THAT HER LANCETS DID NOT FIT WITH HER OT DELICA LANCING DEVICE. 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 PLACED BY THE PATIENT: THE PATIENT MENTIONED THAT ON (B)(6) 2010 AT 6:00PM, THE PATIENT WAS UNABLE TO TEST DUE TO AN ISSUE WITH HER LANCETS WOULD NOT FIT INTO HER OT DELICA LANCING DEVICE GIVEN TO HER BY HER PHYSICIAN. THE PATIENT MENTIONED THAT SHE HAD LOST HER OT LANCING DEVICE; THEREFORE, THE PHYSICIAN HAD PROVIDED HER A OT DELICA LANCING DEVICE. THE FOLLOWING DAY AT AN UNSPECIFIED TIME, SHE DEVELOPED "HIGH BLOOD SUGAR SYMPTOMS". SHE DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, EXACT SYMPTOMS SHE HAD EXPERIENCED, VERIFY WHETHER SHE DID NOT TREAT HERSELF AND HOW LONG SYMPTOMS LASTED. LANCETS WERE SENT TO THE PATIENT. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SINCE SHE DID NOT HAVE THE CORRECT LANCETS FOR HER ONE TOUCH DELICA, SHE WAS UNABLE TO TEST, AND THE FOLLOWING DAY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening