BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2110585 · Received June 1, 2011

    Report

    Report Number
    2939301-2011-04503
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K053529. 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) 2011 ALLEGING AN ERROR 5 MESSAGE ON HER ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN ON (B)(6) 2011 AT 7:00PM. SHE WAS ABLE TO OBTAIN READINGS EARLIER THAT DAY; HOWEVER, DOES NOT RECALL THE READINGS. THE PATIENT CLAIMS THAT AROUND 7:00PM, DUE TO NOT BEING ABLE TO TEST AND OBTAINING THE ERROR 5 MESSAGE, SHE ENDED UP "NOT HERSELF". SHE WAS UNABLE TO EXPLAIN HOW SHE WAS FEELING. HER HUSBAND CONTACTED EMS AND DID NOT ATTEMPT TO TEST OR TREAT THE PATIENT. WHEN THE PARAMEDICS ARRIVED THEY TESTED THE PATIENT USING THEIR METER AND OBTAINED A 64 MG/DL AND TREATED THE PATIENT WITH A GLUCAGON INJECTION. THE PATIENT FELT BETTER AFTER TREATMENT AND WAS NOT TAKEN TO THE HOSPITAL. WHILE TROUBLESHOOTING IT WAS NOTED THAT THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS INCORRECT AND THE PATIENT WAS INSERTING THE TEST STRIP ON THE SURFACE OF THE TEST STRIP. THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. PATIENT RAN OUT OF SUPPLIES TO RETEST OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERROR 5 MESSAGE, SHE WAS UNABLE TO TEST AND HAD TO RECEIVE TREATMENT BY EMS FOR A BLOOD GLUCOSE RESULT OF 64 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3108422

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R