BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 6477144 · Received April 10, 2017

    Report

    Report Number
    1628664-2017-00101
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 21, 2017
    Report Date
    May 3, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT REPRESENTATIVE AT THE CUSTOMER SITE DISCOVERED THE EXTERNAL WASTE TUBING (PN 7-77701-01) ATTACHED TO THE CUSTOMER'S ISYSTEM ANALYZERS WAS NOT CONFIGURED AS REQUIRED PER THE OPERATIONS MANUAL WHICH STATES, "GRAVITY FLOW TO A DRAIN AT FLOOR LEVEL OR EXTERNAL PUMP TO SINK." THE CUSTOMER'S WASTE TUBING WAS NOT ROUTED TO A FLOOR DRAIN AND IT WAS NOT CONNECTED TO AN EXTERNAL WASTE PUMP. THE WASTE TUBING WAS ROUTED TO PLASTIC TANKS WITH A 3-LITER CAPACITY AND HEIGHTS VARYING FROM 15 TO 20 CENTIMETERS (CMS). AS A RESULT, THE SODIUM HYPOCHLORITE DECONTAMINATION SOLUTION SPILLED ONTO THE FLOOR OF THE LAB CREATING FUMES. TO ADDRESS THE ISSUE, EXTERNAL WASTE PUMPS HAVE SINCE BEEN INSTALLED. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT OPERATIONS MANUAL AND THE ARCHITECT ISYSTEM SERVICE AND SUPPORT MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. A USE ERROR CAUSED THE ISSUE: THE WASTE TUBING CONFIGURATION WAS NOT AS REQUIRED PER THE ARCHITECT SYSTEMS OPERATION MANUAL, WHICH CAUSED THE DECONTAMINATION LIQUID WASTE TO SPILL ONTO THE FLOOR. A DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHILE AT THE CUSTOMER SITE, AN ABBOTT REPRESENTATIVE WITNESSED A DECONTAMINATION PROCEDURE IN PROCESS. DURING THIS TIME, AN INTENSE HYPOCHLORITE ODOR WAS NOTICED THAT CAUSED EYE AND THROAT IRRITATION, DIZZINESS AND TACHYCARDIA FOR THE ABBOTT EMPLOYEE (AS DESCRIBED BY THE EMPLOYEE). THE ABBOTT EMPLOYEE LEFT THE AREA FOR APPROXIMATELY 15 MINUTES TO RECOVER. THE ANALYZER WAS PURGED WITH WATER AND BUFFER TO COMPLETE THE PROCEDURE. UPON INVESTIGATION OF THIS ISSUE, THE ABBOTT EMPLOYEE FOUND THAT THE ANALYZERS IN THE CUSTOMER LAB DID NOT HAVE WASTE PUMPS IN PLACE TO CARRY THE DISINFECTING MATERIAL TO ANY TYPE OF HAZARDOUS WASTE CONTAINER. AS A RESULT, THE DECONTAMINATION PRODUCTS WERE SPILLING ONTO THE LAB FLOOR. IT WAS FURTHER DISCOVERED THAT THE WASTE RECEPTACLES THAT CUSTOMER WAS USING (THREE LITER CAPACITY) VARIED IN HEIGHT SO THAT THE WASTE TUBING FROM THE ANALYZERS DID NOT FIT PROPERLY INTO THE CONTAINERS AND COULD NOT PROPERLY DISCARD THE LIQUID. THERE IS NO FURTHER REPORTED IMPACT TO THE ABBOTT EMPLOYEE OR THE EMPLOYEES OF THE LABORATORY. NO TREATMENT / INTERVENTION BEYOND BASIC FIRST AID (LEAVING THE LAB FOR 15 MINUTES FOR FRESH AIR) WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256927 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 TUBING, WASTE LN: 7-77701-01