BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 12003877 · Received June 15, 2021

    Report

    Report Number
    2250051-2021-00039
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    June 5, 2021
    Report Date
    June 15, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OPERATOR CUT HER RIGHT THUMB WITH THE PIPETTE WHILE DOING THE MONTHLY MAINTENANCE OF THE ORTHO VISION BIOVUE ANALYZER. ORTHO CARE TSS DISCUSSED ALL MAINTENANCE TASKS AND SOLUTIONS USED FOR ORTHO VISION WITH THE ORTHO VISION REFERENCE GUIDE. TSS ALSO REFERRED AND DISCUSSED WITH CUSTOMER ORTHO VISION REFERENCE GUIDE PUB. NO.: (B)(4) SAFEGUARDS AND PRECAUTIONS. CUSTOMER WAS SATISFIED WITH DISCUSSION WITH ORTHO CARE TSS ABOUT CONTENT OF ORTHO VISION REFERENCE GUIDE. ORTHO MEDICAL SAFETY OFFICER ASSESSED THIS TYPE OF INJURY AS SERIOUS. THERE IS NO CHANGE IN THE HEALTH OF THE INJURED OPERATOR. NO FURTHER INVESTIGATION WAS REQUIRED BY THE CUSTOMER. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER IS REPORTING A CUT ON THE THUMB OF HER RIGHT HAND WITH THE PIPETTE WHILE DOING THE MAINTENANCE OF THE ORTHO VISION BIOVUE ANALYZER. COMPLAINANT / COMPLAINT REPORTER NAME: (B)(6) MEDICAL TECHNOLOGIST. EVENT DATE: (B)(6) 2021. REPORTED ON: 08 JUNE 2021 BY THE CUSTOMER TO ORTHOCARE HELPDESK. INJURED PERSON NAME: (B)(6) THE OPERATOR WAS WEARING GLOVES. THE CUSTOMER SAID THAT ON (B)(6) 2021 SHE HAS EXPERIENCED A MINOR CUT TO HER RIGHT THUMB WHILE DOING THE ORTHO VISION BIOVUE ANALYZER MONTHLY MAINTENANCE..THE CUSTOMER WAS ON THE STEP OF MONTHLY MAINTENANCE WHERE SHE TURNED TO START CLEANING SURFACE OF INCUBATOR. THE CUSTOMER SAID THAT SHE DID NOT DRAW BLOOD FROM HER INJURY BUT IT WAS A SLIGHT LACERATION. THE CUSTOMER REPORTED THAT HE WENT TO MEDICAL DOCTOR AS PER LABORATORIES PROCEDURES AND THAT SOME SEROLOGICAL TESTING WAS DONE IMMEDIATELY WITH NEGATIVE RESULTS (NO FURTHER DETAIL WAS PROVIDED). THE CUSTOMER ASKED ORTHO CARE IF ORTHO VISION BIOVUE ANALYZER' S PROBE IS CONSTANTLY DECONTAMINATED. THE CUSTOMER IS NOT FOLLOWING ANY MEDICATION OR THERAPY AND DID NOT MISS ANY DAY OF HER WORK DUE TO THE REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894139 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1