BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXLAB

    MDR report key: 25157655 · Received May 13, 2026

    Report

    Report Number
    3010825766-2026-00003
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 13, 2026
    Manufacturer
    INPECO SA
    Product Code
    JQP
    UDI-DI
    07640172340004
    PMA / PMN Number
    (K)121012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED AN INCIDENT IN WHICH A PATIENT SAMPLE TUBE SPLASHED SAMPLE INTO THE OPERATOR'S EYE DURING A RECOVERY PROCEDURE ON THE FLEXLAB (B)(6). THE EVENT INVOLVED DECAPPER MODULE 3 (DCM-3) THAT IS A COMPONENT OF FLEXLAB SYSTEM AIMED FOR CAP REMOVAL BEFORE THE ANALYTICAL TEST. A TUBE THAT HAD BEEN INCORRECTLY IDENTIFIED AS CAPPED BY THE VISION SYSTEM WAS ROUTED TO DCM-3. ACCORDING TO INFORMATION PROVIDED BY THE DISTRIBUTOR, IT HAS BEEN DISCOVERED THAT THE SAMPLE TUBE TYPE CONFIGURED ON THE VISION SYSTEM DID NOT EXACTLY MATCH THE REAL SAMPLE TUBE MEASURES/TYPE: THIS MISALIGNMENT LED TO VISION SYSTEM NOT BEING ABLE TO CORRECTLY IDENTIFY THE SAMPLE TUBE CAP PRESENCE. DURING THE DECAPPING PROCESS, THE DECAPPING TEETH PIERCED THE TUBE WALL, CAUSING THE TUBE REMAINING STUCK INSIDE THE DECAPPER HEAD. THE SYSTEM GENERATED THE ERROR MESSAGE: "108A HEAD UP FAILURE." THE OPERATOR THEN FOLLOWED THE DOCUMENTED RECOVERY PROCEDURE ASSOCIATED WITH THIS ERROR, DESCRIBED AS: "AN UNCAPPED SAMPLE TUBE WAS MISTAKENLY SENT TO THE DECAPPER MODULE AND IS LODGED IN THE DECAPPER HEAD." ALTHOUGH THE RECOVERY STEPS WERE COMPLETED, THE TUBE REMAINED STUCK IN THE DECAPPER HEAD. AS THE TUBE COULD NOT BE REMOVED USING THE ERROR RECOVERY PROCEDURE DISPLAYED ON THE USER INTERFACE, THE OPERATOR MANUALLY MANIPULATED THE TUBE IN AN ATTEMPT TO RELEASE IT: THIS IS AN ACTION NOT DESCRIBED IN THE RECOVERY INSTRUCTIONS. WHEN THE TUBE FINALLY DETACHED, RESIDUAL LIQUID SPLASHED ONTO THE OPERATOR'S FACE AND EYES. AT THE TIME OF THE INTERVENTION, THE OPERATOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AS REPORTED IN THE OPERATIONS MANUAL IMMEDIATELY FOLLOWING THE EVENT, THE OPERATOR WASHED HIS FACE IN THE BATHROOM AND LATER RINSED HIS EYES WITH SALINE SOLUTION. THE SAME DAY, OR THE FOLLOWING DAY, THE OPERATOR SOUGHT MEDICAL EVALUATION AT THE HOSPITAL AS A PRECAUTIONARY MEASURE. SUBSEQUENT UPDATES INDICATED THAT THE OPERATOR INITIALLY REPORTED NORMAL FINDINGS FROM THE FIRST MEDICAL EVALUATION. HOWEVER, THE OPERATOR LATER EXPERIENCED SYMPTOMS INCLUDING HEADACHE, NAUSEA, STOMACH DISCOMFORT, AND OCCASIONAL BLURRED VISION. ADDITIONAL MEDICAL FOLLOW-UPS AND EXTENDED MONITORING WERE RECOMMENDED. AT THE TIME OF THE LATEST UPDATE PROVIDED BY THE DISTRIBUTOR, NO NEW CLINICAL FINDINGS HAD BEEN REPORTED: FURTHER BLOOD TESTING WAS SCHEDULED APPROXIMATELY SEVEN WEEKS AFTER THE INCIDENT.

    Description of Event or Problem · 0

    ACCORDING TO INFORMATION PROVIDED BY THE DISTRIBUTOR, THE CUSTOMER REPORTED A PATIENT SAMPLE TUBE SPLASHED IN THE CUSTOMERS EYE WHEN MANUALLY REMOVING THE TUBE ON THE FLEXLAB. THE CUSTOMER WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). THE SAMPLE TUBE WAS ROUTED TO THE DECAPPER MODULE 3 (DCM-3) WITH NO CAP AND THE DECAPPING TEETH DUG INTO THE TUBE REQUIRING CUSTOMER MANUAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464713 FLEXLAB LABORATORY AUTOMATION SYSTEM JQP INPECO SA 07640172340004

    Patients

    Seq Age Sex Outcome Treatment
    1