BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 16001630 · Received December 18, 2022

    Report

    Report Number
    3016438761-2022-00592
    Event Type
    Malfunction
    Date Received
    December 18, 2022
    Date of Event
    November 25, 2022
    Report Date
    January 20, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3002809144-2022-00436 ((B)(4), GERMANY AS MANUFACTURING SITE) WITH SUSPECT MEDICAL DEVICE OF ARCHITECT TOTAL BILIRUBIN, (B)(4). AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED TO ARCHITECT C16000, (B)(4) ((B)(4), TX AS MANUFACTURING SITE), WHICH IS THIS REPORT. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    FIELD SERVICE IDENTIFIED AND DETERMINED THE AERO CUV PR DRY THE LIKELY CAUSE FOR THE FALSELY LOW TOTAL BILIRUBIN RESULTS AS THE MODULES CUVETTE SHOWED SIGNS OF BEING DIRTY/CONTAMINATED. THE AERO CUV PR DRY WAS CLEANED TO RESOLVE THE ISSUE. THE MODULE FUNCTION WAS VERIFIED WITH A CONTROL RUN. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. A REVIEW OF THE ARCHITECT C16000, SERIAL (B)(6) SERVICE HISTORY, REVEALED NO ADDITIONAL ISSUES OF FALSE LOW TOTAL BILIRUBIN RESULTS REPORTED PRE OR POST FIELD SERVICE INTERVENTION FOR THE CURRENT TICKET. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR POTENTIAL NONCONFORMANCES APPLICABLE TO THE COMPLAINT ISSUE. NO PRODUCT DEFICIENCY WAS IDENTIFIED. SECTION B5, EVENT DESCRIPTION UPDATED FROM FALSE ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS THAT REPEATED LOWER AS STATED ON THE INITIAL REPORT TO FALSE DEPRESSED ARCHITECT TOTAL BILIRUBIN RESULTS THAT REPEATED HIGHER ON THE THIS CORRECTED REPORT. SECTION H6, MEDICAL DEVICE PROBLEM CODE UPDATED FROM A090809 HIGH TEST ON THE INITIAL REPORT TO A090810 LOW TEST ON THIS CORRECTED REPORT.

    Description of Event or Problem · 0

    THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS ON 4 SAMPLES THAT REPEATED LOWER WHEN PROCESSING ON THE ARCHITECT C16000. THE ACCOUNT USES A REFERENCE RANGE OF 3.4 TO 20.5 UMOL/L. (B)(6) (FEMALE, 32 YEAR OLD, HAN/CHINESE) TESTED 1.7 REPEATED 7.2 UMOL/L. (B)(6) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 1.40 REPEATED 12.4 UMOL/L. (B)(6) (FEMALE, 28 YEAR OLD, HAN/CHINESE) TESTED 3.1 REPEATED 8.1 UMOL/L. (B)(6) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 0.8 REPEATED 7.2 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE ACCOUNT GENERATED FALSE DEPRESSED ARCHITECT TOTAL BILIRUBIN RESULTS ON 4 SAMPLES THAT REPEATED HIGHER WHEN PROCESSING ON THE ARCHITECT C16000. THE ACCOUNT USES A REFERENCE RANGE OF 3.4 TO 20.5 UMOL/L. SID (B)(6) (FEMALE, 32 YEAR OLD, HAN/CHINESE) TESTED 1.7 REPEATED 7.2 UMOL/L. SID (B)(6) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 1.40 REPEATED 12.4 UMOL/L. SID (B)(6) (FEMALE, 28 YEAR OLD, HAN/CHINESE) TESTED 3.1 REPEATED 8.1 UMOL/L. SID (B)(6) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 0.8 REPEATED 7.2 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152426 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Female CC TOTAL BILI (2750T), 06L45-22, UNKNOWN.| CC TOTAL BILI (2750T), 06L45-22, UNKNOWN.