BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2132660 · Received June 17, 2011

    Report

    Report Number
    2939301-2011-04951
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) 3 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 (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS ON HER ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS; HOWEVER, THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT. THE FOLLOWING IS BASED ON THE INITIAL CALL PLACED BY THE PATIENT. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AROUND 4:00PM. SHE TESTED AND OBTAINED 2 RESULTS WHICH WERE GREATER THAN 20 MINUTES FROM ONE ANOTHER; HOWEVER, DID NOT PROVIDE THE READINGS. THE PATIENT DID NOT TAKE ANY ACTION AFTER TESTING HER BLOOD GLUCOSE. APPROXIMATELY 7.5 HOURS LATER, THE PATIENT FELT COLD, FEVERISH AND EXPERIENCED COLD SWEATS. THE PATIENT DID NOT SEEK ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, BACK TO BACK READINGS, HOW LONG SYMPTOMS LASTED AND CLARIFICATION ON WHETHER OR NOT SHE SELF-TREATED DUE TO THE ALLEGED ISSUE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERRATIC READINGS, THEY LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3113872

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening