BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECSYS FOLATE III

    MDR report key: 15188515 · Received August 8, 2022

    Report

    Report Number
    1823260-2022-02366
    Event Type
    Injury
    Date Received
    August 8, 2022
    Date of Event
    July 11, 2022
    Report Date
    September 2, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGN
    UDI-DI
    04015630939695
    PMA / PMN Number
    K082340
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION IS ROCHE FIELD APPLICATION SPECIALIST (FAS). ROCHE MEDICAL ASSESSMENT STATES: TOBRAMYCIN OPHTHALMIC OINTMENT IS A TOPICAL ANTIBIOTIC INDICATED WHERE SUPERFICIAL BACTERIAL OCULAR INFECTION OR A RISK OF BACTERIAL OCULAR INFECTION EXISTS. EYE TISSUE DAMAGE DIRECTED FROM OUTSIDE BY A SPLASH OF IRRITANT SUBSTANCE AFFECT PRIMARILY CONJUNCTIVA, CORNEA AND ANTERIOR CAVITY. THE INITIAL INJURY MAY PROMPTLY GET COMPLICATED BY A SECONDARY INFECTION. PREVENTIVE ADMINISTRATION OF TOPICAL ANTIBIOTICS IS A REASONABLE MEDICAL MEASURE WIDELY FOLLOWED. BENEFIT OF PREVENTIVE ANTIBIOTICS OUTWEIGHS THE RISK OF COMPLICATIONS DUE TO INFECTION. PRODUCT LABELING PROVIDES THE METHOD OF PREVENTION: "WEAR PROTECTIVE GLOVES/PROTECTIVE CLOTHING/EYE PROTECTION/FACE PROTECTION." THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A PRODUCT HANDLING ISSUE AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF AN INJURY TO THE TECHNICIAN WHILE CHECKING FOR FILM ON THE ELECSYS FOLATE III (FOLATE III) REAGENT OF A COBAS E801 MODULE SERIAL NUMBER (B)(4). A FILM ALARM OCCURRED AND THE TECHNICIAN REPORTEDLY REMOVED THE REAGENT FROM THE INSTRUMENT TO CHECK FOR BUBBLES. WHILE CHECKING THE REAGENT, THE TECHNICIAN ALLEGEDLY SPLASHED THE REAGENT IN HER EYE. THE TECHNICIAN WAS WEARING GLOVES AND A LAB COAT; SHE WAS NOT WEARING FACE OR EYE PROTECTION. THE TECHNICIAN FLUSHED HER EYE WITH WATER AND WENT TO THE URGENT CARE CENTER WHERE THEY REPORTEDLY SUGGESTED SHE SEE AN EYE SPECIALIST. THE TECHNICIAN REPORTEDLY SAW AN OPHTHALMOLOGIST WHO PROVIDED HER WITH TOBRAMYCIN EYE OINTMENT. THE OPHTHALMOLOGIST ALLEGEDLY DISCOVERED "DAMAGE" TO HER EYE BUT DID "NOT BELIEVE IT IS PERMANENT." CLARIFICATION WAS REQUESTED RELATED TO THE ALLEGED "DAMAGE" TO THE EYE BUT THE DOCTOR "DID NOT ELABORATE" ON THIS STATEMENT. THE TECHNICIAN IS CURRENTLY REPORTEDLY "DOING OK" AND IS BACK AT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153990 ELECSYS FOLATE III FOLIC ACID TEST SYSTEM CGN ROCHE DIAGNOSTICS FOLATE G3 ASKU 04015630939695

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention