BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPPER SULFATE SOLUTION

    MDR report key: 433890 · Received December 20, 2002

    Report

    Report Number
    2244894-2002-00001
    Event Type
    Injury
    Date Received
    December 20, 2002
    Date of Event
    May 19, 2002
    Report Date
    June 18, 2002
    Manufacturer
    EMD CHEMICALS INC.
    Product Code
    JPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME TO BLOOD DONOR FACILITY TO DONATE BLOOD, WAS TESTED ROUTINELY, AND PASSED AS ABLE TO DONATE. ONE PINT BLOOD WAS TAKEN. PATIENT BECAME ILL AND EXPERIENCED WEAKNESS, DIZZINESS, AND NAUSEA. DONOR WAS TAKEN BY AMBULANCE TO THE HOSPITAL AND WAS RELEASED TWO DAYS LATER. THE DONOR HEMATOCRIT PERFORMED IN HOSPITAL WAS FOUND TO BE LOW. BLOOD DONOR LAB RETESTED UNIT OF DONATED BLOOD USING SAME LOT OF COPPER SULFATE SOLUTION AS PREVIOUSLY USED. THIS TEST ALSO GAVE LOW UNACCEPTABLE READING. BOTH INITIAL QC AND RETESTS BY LAB ON THE LOT OF COPPER SULFATE SOLUTION SHOWED IT TO BE WITHIN SPECIFICATIONS. BLOOD DONOR FACILITY FOUND NO PROBLEMS WITH USE OF THE LOT OF SOLUTION IN OTHER PATIENT TESTS. IT WAS CONCLUDED BY BOTH USER FACILITY AND MANUFACTURER THAT THERE WAS NO DEFECT IN THE COPPER SULFATE SOLUTION USED IN THE TESTING OF THE PATIENT. IT IS UNLIKELY THAT THE COPPER SULFATE SOLUTION CONTRIBUTED TO THE ADVERSE EVENT. IT IS POSSIBLE THAT A USER ERROR OCCURRED IN HANDLING OF THE PORTION OF THE SOLUTION USED, THE PATIENT SAMPLE, OR THE EVALUATION OF THE TEST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COPPER SULFATE SOLUTION COPPER SULFATE SOLUTION FOR SPECIFIC GRAVITY TESTING OF BLOO JPH EMD CHEMICALS INC. NA 2050

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization