BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSCAN KOVAC'S REAGENT

    MDR report key: 25059416 · Received May 1, 2026

    Report

    Report Number
    2919016-2026-00001
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 1, 2026
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LQM
    UDI-DI
    15099590655204
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECKMAN COULTER COMPLAINT HANDLING UNIT INVESTIGATOR (CHU) REVIEWED THE EVENT INFORMATION AND TWO PHOTOS THAT WERE PROVIDED. ONE PHOTO SHOWED THE CAP SHRINK-WRAPPED CROOKED ON THE BOTTLE. THE BOX IN THE PHOTO HAD EVIDENCE OF REAGENT LEAKAGE BASED ON THE YELLOW-COLORED STAIN. THE SECOND PHOTO AGAIN DEMONSTRATED STAIN FROM LEAKED REAGENT ON THE PRODUCT BOX. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR B1010-41A KOVAC¿S REAGENT 30ML LOT 2026-11-13. NO ANOMALIES DURING MANUFACTURING WERE NOTED. ALL CAP TORQUE MEASUREMENTS WERE WITHIN SPECIFICATION. NO DAMAGED OR LEAKING BOTTLES WERE OBSERVED DURING QUALITY CONTROL INSPECTION. LOT MET ALL FINAL QUALITY CONTROL CRITERIA PRIOR TO RELEASE. RETENTION INSPECTION WAS PERFORMED ON B1010-41A KOVAC¿S REAGENT 30ML LOT 2026-11-13. THE RETENTION SAMPLE WAS FULLY FILLED WITH NO SIGNS OF DAMAGE OR LEAKAGE, THE CAP WAS CORRECTLY PLACED, AND THE BOTTLE SHRINK WRAPPING WAS SECURE. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT OF KOVAC¿S REAGENT AND NO FURTHER ISSUES WERE REPORTED. SECTION A2, A3, A4, A5 AND A6: INFORMATION NOT PROVIDED BY CUSTOMER. SECTION E1, INITIAL REPORTER TELEPHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER IN JAPAN REPORTED ONE BOTTLE OF B1010-41A MICROSCAN KOVAC¿S REAGENT LOT 2026-11-13 ARRIVED LEAKING. THE PACKAGE ARRIVED WITH THE OUTER PACKAGING CONTAMINATED WITH THE REAGENT. UPON INSPECTION OF THE BOTTLE, IT WAS NOTED THE CAP WAS INSUFFICIENTLY TIGHTENED AND SHRINK-WRAPPED TO THE BOTTLE IN A TILTED STATE. AT THE TIME OF DISCOVERY, THE ODOR OF THE LEAKED REAGENT WAS EXTREMELY STRONG, AND TWO STAFF MEMBERS FELT UNWELL REPORTING ONGOING COLD-LIKE SYMPTOMS, EYE AND RESPIRATORY IRRITATION. ONE OF THE TWO EXPOSED STAFF MEMBERS DID SEEK OUT MEDICAL ATTENTION AND WAS PRESCRIBED MEDICATION. BOTH STAFF MEMBERS HAVE FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117628 MICROSCAN KOVAC'S REAGENT GRAM NEGATIVE IDENTIFICATION PANEL LQM BECKMAN COULTER, INC. RGNT KOVAC'S 30ML 15099590655204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other