BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 6451306 · Received March 31, 2017

    Report

    Report Number
    1628664-2017-00088
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 17, 2017
    Report Date
    May 12, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER WAS DISPATCHED TO THE ACCOUNT AND CONFIRMED THE CAUSE OF THE LIQUID LEAKING OUT OF THE ANALYZER WAS DUE TO THE EXTERNAL WASTE TUBING (PN 7-77701-01). THE WASTE TUBING WAS BENT AT 90 DEGREES IN A CORNER OF THE LAB. THE BENT WASTE TUBING RESTRICTED FLOW OF THE DECONTAMINATION FLUID WHICH BACKED UP AND LEAKED OUT OF THE INSTRUMENT. THE WASTE TUBING WAS ADJUSTED TO REMOVE THE 90-DEGREE BEND WHICH RESOLVED THE INSTRUMENT LEAKING. THE ANALYZER WAS RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A LABELING REVIEW, AND AN INSTRUMENT SERVICE REVIEW. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ARCHITECT SYSTEM OPERATIONS MANUAL INSTRUCTS THE CUSTOMER TO CONTACT ABBOTT CUSTOMER SUPPORT TO PERFORM THE INTERNAL DECONTAMINATION IF IT IS SUSPECTED THE ANALYZER MODULE IS CONTAMINATED. THE DECONTAMINATION PROCEDURE THE CUSTOMER DESCRIBED IS ALSO DIFFERENT THAT THE INTERNAL DECONTAMINATION PROCEDURE USED BY ABBOTT FIELD SERVICE/CUSTOMER SUPPORT. THE CONCENTRATION OF SODIUM HYPOCHLORITE THE CUSTOMER USED AT THE TIME OF THE INCIDENT (2.6%) EXCEEDS THE 0.5% SOLUTION RECOMMENDED FOR THE ANALYZER. THE WASTE TUBING ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. SERVICE HISTORY REVIEW FOR ARCHITECT I2000SR ANALYZER SERIAL NUMBER (B)(4) IDENTIFIED NO CONTRIBUTING FACTORS TO THE CUSTOMER ISSUE, AND DID NOT FIND ANY PRIOR ISSUES THAT INCLUDED WASTE TUBING (7-77701-01) OR BLEACH FUME EXPOSURE ASSOCIATED WITH ANALYZER DECONTAMINATION. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE USER OBSERVED LIQUID COMING OUT OF THE BOTTOM BACK PART OF THE ARCHITECT I2000SR ANALYZER, AND SAW THAT THE ANALYZER WASTE TUBING WAS BENT. THE BENT TUBING PREVENTED THE WASTE FROM FLOWING AWAY FROM THE ANALYZER AND INTO THE DRAIN. THE CUSTOMER REMOVED THE BACK COVER OF THE ANALYZER AND CORRECTED THE TUBING ROUTE, THEN PROCEEDED TO CLEAN THE BASE OF THE INSTRUMENT. NO ACCUMULATED LIQUID WAS FOUND INSIDE THE ANALYZER. THE USER REPORTED THE AREA WHERE THE ANALYZER IS LOCATED IS SMALL, ABOUT 4.5 BY 4.5 METERS AND HAS NO VENTILATION. THE SOLUTION USED FOR DECONTAMINATION WAS COMMERCIAL 5.25% HYPOCHLORITE DILUTED IN EQUAL PARTS WATER (1000 CM WATER WITH 1000 CM HYPOCHLORITE). WHILE COMPLETING THE ANALYZER DECONTAMINATION, THE USER REPORTED THAT THEY BECAME DIZZY, THEIR EYES WERE RED, THEY HAD TROUBLE BREATHING, AND FELT LIKE VOMITING. THE USER WAS THEN TAKEN TO THE EMERGENCY ROOM. THE USER WAS DIAGNOSED WITH BRONCHIAL HYPER REACTIVITY. THE USER RECEIVED NEBULIZER TREATMENTS (BERODUAL, 3 DOSES) DUE TO DIFFICULTY BREATHING. THE USER ALSO RECEIVED PLACIL AS A RESULT OF THE INCIDENT. NO TREATMENT WAS PROVIDED FOR THE EYE IRRITATION. THE PATIENT REPORTED THAT APPROXIMATELY THREE DAYS FOLLOWING THE TREATMENT THEY HAD SOME DISCOMFORT WITH TREMBLING IN HER HANDS. THREE DAYS FOLLOWING THE INCIDENT, THE USER RETURNED TO WORK IN THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232780 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention