BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATA MEDICAL ASSOCIATES CALCIUM PLUS REAGENT

    MDR report key: 134231 · Received November 20, 1997

    Report

    Report Number
    1650060-1997-00001
    Event Type
    Injury
    Date Received
    November 20, 1997
    Date of Event
    October 22, 1997
    Report Date
    October 24, 1997
    Manufacturer
    DATA MEDICAL ASSOCIATES, INC.
    Product Code
    CJY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    WHILE UNDERGOING ROUTINE MEDICAL TESTING, A PATIENT WAS IDENTIFIED AS HAVING AN ELEVATED SERUM CALCIUM LEVEL. THIS SERUM CALCIUM LEVEL WAS DETERMINED DURING AN IN-CONTROL ASSAY UTILIZING DATA MEDICAL ASSOCIATES INC. (DMA) CATALOG #1265, CALCIUM PLUS REAGENT. ALL OTHER PATIENT SAMPLES TESTED AT THIS TIME WERE WITHIN THE NORMAL RANGE. ON THE BASIS OF TEST RESULT, HER DOCTOR ADMITTED HER TO A HOSPITAL FOR THE PURPOSE OF LOWERING THE SERUM CALCIUM LEVEL. PRIOR TO STARTING TREATMENT, A SECOND ASSAY WAS PERFORMED ON A FRESH SAMPLE OF SERUM UTILIZING A CALCIUM REAGENT OF ANOTHER METHODOLOGY. THIS SECOND ASSAY FOUND A NORMAL SERUM CALCUIM LEVEL TO BE PRESENT. DUE TO THESE TEST RESULTS, A THIRD ASSAY OF ANOTHER METHODOLOGY WAS PERFORMED. THE TWO ASSAYS PERFORMED AFTER SHE WAS ADMITTED TO THE HOSPITAL FOUND THAT THE PATIENT'S SERUM CALCIUM LEVEL WAS NORMAL. THE MEDICAL TECHNOLOGIST REPORTING THIS INCIDENT TO DMA CONVEYED IN A PHONE CONVERSTATION THAT AFTER TWO TESTS DETERMINED SHE HAD A NORMAL SERUM CALCIUM LEVEL, SHE WAS RELEASED FROM THE HOSPITAL WITHOUT RECEIVING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATA MEDICAL ASSOCIATES CALCIUM PLUS REAGENT SERUM CALCIUM CLINICAL CHEMISTRY REAGENT (ARSENAZO III) CJY DATA MEDICAL ASSOCIATES, INC. NA MI19

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R 8. PREDNISONE 100MG FOR 5 DAYS FOLLOWING CHEMO (| 7. VINCHRISTINE 1MG BY SYRINGE (UNK TO UNK)| UNK)| 5. ZOFRAM 32 MG IN 50CC D5 WATER (UNK TO UNK)| UNK TO UNK),| 6. CYTOXAN 1300 MG IN 500CC D5 WATER (UNK TO UNK)| 9. HEPARIN/SALINE FLUSH OF PORTACATH SITE (UNK TO| 2. TYLENOL III| 3. D5 1/2 NS IN 20 KCL N SALINE| 4. DECADRON 20 MG (UNK TO UNK)| 1. COUMADIN