BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 CUVETTE SEGMENT

    MDR report key: 1903816 · Received November 20, 2010

    Report

    Report Number
    1628664-2010-00429
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CALCIUM REAGENT LIST 3L79-21 LOT 42251UN10 CHOLESTEROL REAGENT LIST 7D62-20 LOT 82054HW00 AND ULTRA HDL LIST 3K33-21 LOT 72558Y890 THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUVETTE SEGMENT BECAME DAMAGED AND DISCREPANT LOW RESULTS WITH THE PATIENT RESULT FLAG "<" WERE GENERATED. DOCUMENTATION INDICATES A CUVETTE SEGMENT LN 02P75-01 WAS WARPED; DEFLECTED DOWNWARD AT THE BOTTOM BRACE. CUVETTES ARE NOW SITTING TOO LOW IN THE MIDDLE GENERATING RESULTS WITH THE PATIENT FLAG "<", WHICH MEANS THE RESULT IS OUTSIDE THE DYNAMIC OR LINEAR RANGE. RETESTING IN AN UNDAMAGED CUVETTE SEGMENT GENERATES THE EXPECTED RESULTS. SUBSEQUENT INFORMATION INDICATES THE DISCREPANT RESULTS ARE THOSE WITH THE PATIENT RESULT FLAG "<" THAT ARE ACCEPTABLE WHEN REPEATED AS DESCRIBED BY THE CUSTOMER. AN EVALUATION WAS PERFORMED REGARDING THE DISCREPANT LOW RESULTS FLAGGED "<" THAT WERE ACCEPTABLE UPON REPEAT TESTING. TROUBLESHOOTING FOUND THE CAUSE TO BE BROKEN CUVETTE SEGMENTS. SYSTEM LOGS DID NOT REVEAL ANY SYSTEM ERROR CODES ASSOCIATED WITH THE RESULTS FLAGGED "<". PATIENT RESULT FLAGS PROVIDE ADDITIONAL INFORMATION ABOUT A RESULT AND INDICATE THE RESULT MAY NEED TO BE REVIEWED. PATIENT RESULT FLAGS ARE DESCRIBED ADDRESSED IN THE PRODUCT LABELING. THE ISSUE FOR BROKEN CUVETTES IS BEING FURTHER INVESTIGATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INCIDENT HAS BEEN DETERMINED TO BE RELATED TO A MALFUNCTION AND A PRODUCT DEFICIENCY IDENTIFIED IN DEC 2014. AN INVESTIGATION IDENTIFIED CUVETTES LOCATED WITHIN BROKEN CUVETTE SEGMENTS LIST NUMBER 2P75-01. THIS CAUSED THE SPECIFIC CUVETTES TO BE LOWER THAN THE DESIGNED HEIGHT, WHICH RESULTED IN SAMPLES NOT WICKING-OFF INTO THE CUVETTES DURING DISPENSE BECAUSE THE SAMPLE PROBE WAS NOT IN CONTACT WITH THE CUVETTE BOTTOM. IN THE CASE WHERE CUVETTE SEGMENTS ARE BROKEN, DISCREPANT RESULTS ARE NOT ALWAYS FLAGGED. NO INJURIES OR IMPACT TO PATIENT MANAGEMENT HAVE BEEN REPORTED DUE TO THIS ISSUE. THE INVESTIGATION DETERMINED THAT IF THE INTEGRITY OF A CUVETTE SEGMENT IS COMPROMISED, CUVETTES MAY BECOME MISALIGNED DURING THE COURSE OF NORMAL INSTRUMENT OPERATION, AND THE SAMPLE PROBE MAY FAIL TO MAKE CONTACT WITH THE BOTTOM INNER SURFACE OF AFFECTED CUVETTE(S), WHICH MAY LEAD TO INCORRECT RESULTS. A MANDATORY TECHNICAL SERVICE BULLETIN (TSB) ON ALL C4000 INSTRUMENTS (EFFECTIVE JANUARY 15, 2015) WAS ISSUED WITH AN 18-MONTH COMPLETION TIMEFRAME. THIS MANDATORY TSB INSTRUCTS FIELD SERVICE TO: INSPECT ALL CUVETTE SEGMENTS ON THE C4000 SYSTEM AND IN CUSTOMER INVENTORY (IF ANY) AND ON THE C4000 SYSTEM. REPLACE ANY IDENTIFIED BROKEN CUVETTE SEGMENT. REPLACE ANY OLD SEGMENT (LIST NUMBER 2P75-01) WITH THE NEW CUVETTE SEGMENT (7-207043-01) A WORLDWIDE QUALITY HOLD FOR 2P75-01 INCLUDING FINAL DISPOSITION TO INSPECT HAS BEEN ISSUED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT C4000 ANALYZER HAS GENERATED DISCREPANT CALCIUM RESULTS ON 2 PATIENT SAMPLES. THE INITIAL RESULT FOR PATIENT #1 WAS <2.0 MG/DL AND THE RETEST RESULT WAS 9.8 MG/DL. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C4000 CUVETTE SEGMENT C4 CUVETTE SEGMENT JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C4 CUVETTE SEGMENT| ARCHITECT C4 CUVETTE SEGMENT