BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 15394058 · Received September 9, 2022

    Report

    Report Number
    3016438761-2022-00409
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 19, 2022
    Report Date
    September 30, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: MULTIPLE PATIENTS: (B)(6). ALL AVAILABLE PATIENT INFORMATION IS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT, PERFORMED TROUBLESHOOTING PROCEDURES, AND REPLACED PARTS INCLUDING THE VALVE, VACUUM (ROHS) (7-76446-01) ON THE I2000SR ANALYZER, SERIAL NUMBER (B)(6), AS IT WAS FOUND TO BE CLOGGED. THE VALVE, VACUUM (ROHS) (7-76446-01) WAS DETERMINED TO BE THE LIKELY CAUSE OF THE ISSUE. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY SIMILAR ISSUES OR TRENDS RELATED TO THE ARCHITECT SYSTEM OR THE COMPLAINT ISSUE. A REVIEW OF HISTORICAL DATA ASSOCIATED WITH THE VALVE, MANIFOLD KIT (ROHS) DID NOT IDENTIFY ANY TRENDS OR NON-CONFORMANCES. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR ANALYZER, SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED AN INCREASE IN EXPECTED VALUES FOR THE POSITIVE CONTROL FOR ARCHITECT HAVAB-IGG. THE CUSTOMER¿S ESTABLISHED RANGE FOR THE POSITIVE CONTROL IS 1.03-3.53 S/CO. THE FOLLOWING CONTROL DATA WAS PROVIDED: ON (B)(6) 2022: 2.47 S/CO, ON (B)(6) 2022: 2.38 S/CO, ON (B)(6) 2022: 2.55 S/CO, ON (B)(6) 2022: 2.50 S/CO, ON (B)(6) 2022: 2.81 S/CO. NEGATIVE CONTROLS WERE WITHIN RANGE WITH NO REPORTED INCREASE. VALUES WERE VERIFIED IN THE PACKAGE INSERT. THE CUSTOMER PERFORMED A RETEST USING 3 SAMPLES THAT WERE PREVIOUSLY TESTED ON (B)(6)2022 USING THE ARCHITECT HAVAB-IGG ASSAY. THE RESULTS WERE DISCREPANT. THE FOLLOWING DATA WAS PROVIDED: ID: (B)(4). ON (B)(6) 2022: RESULT: 0.47 (S/CO), ON (B)(6) 2022: RETEST: 2.46/ 1.76/1.91/2.63/2.38/1.16 (S/CO). ID:(B)(4). ON (B)(6) 2022: RESULT: 1.74 (S/CO), ON (B)(6) 2022: RETEST: 0.88/0.37 /0.96/0.45/0.61/0/42 (S/CO). ID: (B)(4). ON (B)(6) 2022: RESULT: 1.23 (S/CO), ON (B)(6) 2022: RETEST: 0.79/0, 69/0.38/0.42/0.88 (S/CO). DURING A FOLLOW UP WITH THE CUSTOMER, THE FOLLOWING INFORMATION WAS PROVIDED REGARDING THE REPETITIONS: MODULE 1 AND NTO (SUPPORT LAB): UNIT (S/CO) ID: (B)(4). MODULE 1 = 1.16, NTO= 0.65 (ALINITY). ID: (B)(4). MODULE 1= 0.42, NTO = 0.33 (ALINITY). ID: (B)(4). MODULE 1 = 0.88, NTO = 0.38 (ALINITY). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307651 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC HAVAB IGG RGT 100T, 06C29-27, (B)(6)| ARC HAVAB IGG RGT 100T, 06C29-27, (B)(6)