BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT METER

    MDR report key: 1843068 · Received September 23, 2010

    Report

    Report Number
    2939301-2010-08324
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 26, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL # NOT PROVIDED.THE 510 (K) # IS UNKNOWN SINCE SERIAL # AND NAME OF DEVICE WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ON AUGUST 26, 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A CALCODING ISSUE WITH AN UNKNOWN BLOOD GLUCOSE METER. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2010, AT AN UNSPECIFIED TIME. ACCORDING TO THE PATIENT, SHE DEVELOPED SYMPTOMS OF BLURRY VISION AND DIZZINESS "IMMEDIATELY" AFTER THE ALLEGED ISSUE BEGAN. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT SHE RECEIVED 6 UNITS OF INSULIN FROM AN UNIDENTIFIED HEALTH CARE PROFESSIONAL (HCP) ON (B)(6) 2010. THE INSULIN WAS REPORTEDLY GIVEN PRIOR TO UNDERGOING SURGERY FOR AN UNKNOWN REASON. THAT SAME DAY, THE PATIENT'S BLOOD GLUCOSE WAS TESTED ON AN ER/HOSPITAL METER AND A RESULT OF "306 MG/DL" WAS OBTAINED. THE PATIENT MENTIONED, HOWEVER, THAT SHE HAD SKIPPED A DOSE OF METFORMIN AND GLYBURIDE PRIOR TO THE SURGERY. ALSO, THE PATIENT CLAIMED THAT SHE WAS TREATED WITH MORE INSULIN (UNKNOWN DOSE AND TYPE) AFTER THE SURGERY WAS PERFORMED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, IF THE PATIENT STILL TESTED HER BLOOD GLUCOSE WITH THE REPORTED METER AFTER THE ALLEGED ISSUE BEGAN, IF SHE WAS ABLE TO TEST ON ANY OTHER DEVICE DURING THE TIME OF CONCERN, WHAT HER BLOOD GLUCOSE READINGS WERE BEFORE AND AFTER THE ALLEGED ISSUE BEGAN, AND WHAT ACTIONS THE PATIENT TOOK PRIOR TO THE SURGERY. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT ACTIONS THE PATIENT TOOK IN RESPONSE TO THE ALLEGED ISSUE AND AFTER DEVELOPING THE SYMPTOMS, IF SHE ATTRIBUTED THE SYMPTOMS TO HIGH OR LOW BLOOD GLUCOSE, AND WHAT ACTUAL METER HAD A CALCODING ISSUE. THE PATIENT WAS SENT A REPLACEMENT METER. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE RECEIVED INSULIN TREATMENT FROM AN HCP AFTER THE ALLEGED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R