BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2233803 · Received September 4, 2011

    Report

    Report Number
    2939301-2011-08519
    Event Type
    Injury
    Date Received
    September 4, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 22, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (10/3/2011)-DEVICE EVALUATION: THE METER INVOLVED THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE RETURNED METER FAILED TESTING. THERE WAS CONTAMINATION FOUND ON THE METER¿S PC BOARD. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. THE 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING A POWER ISSUE WITH HER ONE TOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER NOT POWERING ON BEGAN ON (B)(6) 2011, AT 8 PM. SHE STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS) AND DUE TO THE ALLEGED ISSUE ON (B)(6) 2011, AT 7 PM SHE CONTINUED TAKING HER USUAL DOSE OF MEDICATION. THE PATIENT CLAIMED THAT AFTER THE ALLEGED ISSUE STARTED, ON (B)(6) 2011, AT 7 PM, SHE FELT 'SWEATY AND SHAKY'. SHE DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT DUE TO HER SYMPTOMS. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE PATIENT STATED THAT SHE HAD STORED THE SUBJECT METER INSIDE A COOLER WITH HER INSULIN AND IT BECAME WET. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3155821

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening