BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOGLOBIN A1C

    MDR report key: 14250283 · Received April 29, 2022

    Report

    Report Number
    3002809144-2022-00144
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 9, 2022
    Report Date
    April 29, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    PDJ
    UDI-DI
    00380740102746
    PMA / PMN Number
    K130255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINTS FOUND NO TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT NECESSARY. THE CUSTOMER DID NOT WEAR PROTECTIVE EYEWEAR AT THE TIME OF THE INCIDENT. THE CUSTOMER CONFIRMED THERE WAS NO EYE IRRITATION, REDNESS OR ITCHING AND THUS DID NOT SEE A NEED TO SEEK MEDICAL ASSISTANCE. THE CUSTOMER WAS EMAILED SDS SHEET AND ASKED TO FOLLOW LAB PROTOCOL ON LAB EXPOSURES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. BASED ON THE REVIEW OF THE ISSUE, LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, SINCE A USER ERROR IN HANDLING OF THE REAGENT WAS IDENTIFIED (LACK OF PROTECTIVE EYEWEAR), ARCHITECT HEMOGLOBIN A1C IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SPLASH FROM ARCHITECT HBA1C REAGENT INTO EYES WHEN TRYING TO REPLACED EMPTY REAGENT ON ARCHITECT C8000 PROCESSING MODULE. THE CUSTOMER STATES SLIPPED THE HBA1C BOX OUT OF HER HAND WHEN TRYING TO REPLACE EMPTY CONTAINER. THE HBA1C REAGENT SPLASHED INTO THE CUSTOMER EYES. THE CUSTOMER WAS WEARING PPE AT THE TIME OF INCIDENT BUT DID NOT WEAR SAFETY GLASSES AT THAT TIME. THE EYES WERE CLEANED AND RINSED WITH WATER. THERE WAS NO EYE IRRITATION, REDNESS OR ITCHING AND NO OTHER TREATMENT PROVIDED BY PHYSICIAN. NO IMPACT TO OPERATOR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290195 HEMOGLOBIN A1C HEMOGLOBIN A1C TEST SYSTEM PDJ ABBOTT GMBH 4P52-20 60880UQ10 00380740102746

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C8 PROC MOD, 01G06-11, C804215