BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2180332 · Received July 27, 2011

    Report

    Report Number
    2939301-2011-06418
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K021819.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS ON HER ONE TOUCH ULTRASMART METER. 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 ON (B)(6) 2011. ON (B)(6) 2011 AT AN UNSPECIFIED TIME IN THE MORNING SHE TESTED HER BLOOD GLUCOSE AND OBTAINED A 240 MG/DL AND A 140 MG/DL. READINGS WERE DONE LESS THAN 20 MINUTES FROM ONE ANOTHER. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. DUE TO THE ALLEGED ISSUE, THE PATIENT SKIPPED DOSAGE OR STOPPED HER MEDICATION, (VICTOZA 1.8 MGL). AT AROUND 7:00AM THAT MORNING, THE PATIENT SELF-TREATED WITH A GLUCAGON INJECTION. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THE TEST STRIPS WERE NOT EXPIRED AND WAS IN GOOD CONDITION. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, READINGS PRIOR TO THE EVENT, AND WHY THE PATIENT TREATED HERSELF WITH GLUCAGON INJECTION. THE PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. LFS HAS RECEIVED THE PRODUCTS BACK FOR INVESTIGATION. METER AND TEST STRIPS BOTH PAST TESTING. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ERRATIC READINGS, SHE HAD TO SELF-TREAT WITH A GLUCAGON INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3157321

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R