BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2253114 · Received September 19, 2011

    Report

    Report Number
    2939301-2011-09163
    Event Type
    Injury
    Date Received
    September 19, 2011
    Report Date
    September 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER WAS READING "THREE DASHES". PER THE ONETOUCH ULTRA 2-S OWNER'S BOOKLET, THIS MESSAGE APPEARS IF THE METER HAS NOT BEEN CODED OR IF THE CODE NUMBER HAS BEEN LOST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT STATED THE ALLEGED ISSUE BEGAN IN (B)(6) 2011, BUT THE EXACT DATE/TIME WAS NOT SPECIFIED. THE PATIENT REPORTED THAT HE MANAGES HIS DIABETES WITH LANTUS AND APIDRA INSULIN AND CONTINUED WITH HIS NORMAL DOSE OF MEDICATION WHEN HE WAS UNABLE TO CHECK HIS BLOOD GLUCOSE DUE TO THE THREE DASHES. THE PATIENT CLAIMED THAT ON DIFFERENT OCCASIONS IN (B)(6), (B)(6) AND (B)(6) HE SUFFERED FROM HIGH BLOOD GLUCOSE SYMPTOMS DUE TO NOT CHECKING HIS BLOOD GLUCOSE HE WAS FEELING "DIZZY, SWEATING AND WEAK", BUT DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT OTHER THAN CONTINUING TO TAKE HIS INSULIN AT THE PRESCRIBED TIMES. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT TEST STRIPS WERE EXPIRED. THE PATIENT CLAIMED HE WOULD SEE THE THREE DASHES AFTER CODING THE METER. TROUBLESHOOTING COULD NOT BE PERFORMED SINCE THE PATIENT THREW AWAY THE METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2809681

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening