BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5291599 · Received December 11, 2015

    Report

    Report Number
    1052693-2015-02429
    Event Type
    Death
    Date Received
    December 11, 2015
    Date of Event
    November 13, 2015
    Report Date
    December 29, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MANUFACTURER STILL ATTEMPTING TO RECEIVE THE PRODUCT BACK.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MANUFACTURER STILL ATTEMPTING TO RECEIVE THE PRODUCT BACK. IT HAS BEEN CONFIRMED THAT THE PATIENT WAS NOT TAKING INSULIN. THE OBGYN OFFICE INFORMED THAT THEY DO NOT HAVE AN AUTOPSY REPORT, THEREFORE THE CAUSE OF FETUS DEMISE IS UNKNOWN.

    Description of Event or Problem · 1

    FETAL DEMISE RELATED WITH GESTETIONAL DIABETES PATIENT. HEALTH CARE PROFESSIONAL REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS COMPARED WITH PATIENT'S ALTERNATE METER (ABOUT 20MG/DL LOWER). THE CLINIC DIETICIAN, (B)(6) IS REPORTED ON BEHALF OF THE CUSTOMER. THE EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS REQUESTED, BUT NOT PROVIDED. MEDICAL ATTENTION REPORTED DURING THE WEEK PRIOR TO THE EMAIL NOTIFICATION ((B)(6) 2015) AS A RESULT OF THE METER'S READINGS. THE PATIENT WAS PREGNANT AND TAKING MEDICATION / INSULIN TO MANAGE GESTATIONAL DIABETES. METER SERIAL# AND TEST STRIP LOT# REQUESTED, BUT NOT PROVIDED. PRODUCT STORAGE CONDITIONS REQUESTED, BUT NOT PROVIDED. DIETICIAN CONFIRMED NO SYMPTOMS ASSOCIATED WITH THE LOW GLUCOSE. REQUESTED PATIENT LAB VALUES, BUT NOT PROVIDED. ACTUAL METER RESULTS REQUESTED, BUT NOT PROVIDED.

    Description of Event or Problem · 1

    FETAL DEMISE RELATED WITH GESTATIONAL DIABETES PATIENT. HEALTH CARE PROFESSIONAL REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS COMPARED WITH PATIENT'S ALTERNATE METER (ABOUT 20MG/DL LOWER). THE CLINIC DIETICIAN, (B)(6) REPORTS ON BEHALF OF THE CUSTOMER. THE EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS REQUESTED, BUT NOT PROVIDED. MEDICAL ATTENTION REPORTED DURING THE WEEK PRIOR TO THE EMAIL NOTIFICATION (11/13/2015) AS A RESULT OF THE METER'S READINGS. THE PATIENT WAS PREGNANT AND TAKING MEDICATION / INSULIN TO MANAGE GESTATIONAL DIABETES. METER SERIAL# AND TEST STRIP LOT# REQUESTED, BUT NOT PROVIDED. PRODUCT STORAGE CONDITIONS REQUESTED, BUT NOT PROVIDED. DIETICIAN CONFIRMED NO SYMPTOMS ASSOCIATED WITH THE LOW GLUCOSE. REQUESTED PATIENT LAB VALUES, BUT NOT PROVIDED. ACTUAL METER RESULTS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820437 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Death