BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X100 GOLD CAP-GOLD RING

    MDR report key: 24484538 · Received March 2, 2026

    Report

    Report Number
    1125230-2026-00009
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Report Date
    March 2, 2026
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K983952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). NO SAMPLES WERE PROVIDED FOR EVALUATION. WE HAVE NO REMAINING INVENTORY ON THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. THE COMPLAINT IS CLOSED AS CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER ADVISED: "I HAVE HAD SEVERAL COMPLAINTS FROM OP (OUTPATIENT) PROVIDERS ON CALCIUM LEVELS BEING ELEVATED. I THOUGHT THE ISSUE WAS A NEW GENERATION ON CA ON THE ORTHO ANALYZER. HOWEVER, AFTER MUCH INVESTIGATION. OUR CA [CALCIUM] ANALYTE IS RUNNING WITHIN MANUFACTURER SPECIFICATIONS. I EVEN WENT AS FAR TO RUN SAMPLES FROM HRH (ANOTHER LAB SITE), COMPARED BEAUTIFULLY. I RAN MY OWN BLOOD AND COMPARED CMP RESULTS GREEN/GOLD. GOLD TOP SHOWED A POSITIVE BIAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546486 VACUETTE® TUBE 5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X100 GOLD CAP-GOLD RING EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 456018P B251133B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown