BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 13696991 · Received March 8, 2022

    Report

    Report Number
    3016438761-2022-00105
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 8, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL CUSTOMER SERVICE REVIEWED THE MODULE LOGS AND RECOMMENDED THE CUSTOMER OPTIMIZE INSTRUMENT PERFORMANCE AND CALIBRATE ALL PROBES. A SPECIFIC CAUSE FOR THE ISSUE WAS NOT IDENTIFIED. ISSUES WITH SAMPLE INTEGRITY COULD NOT BE RULED OUT. THE ALINITY C SERIAL NUMBER AC02949 WAS CONSIDERED THE LIKELY CAUSE OF THE ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL DISCREPANT SODIUM AND CARBON DIOXIDE RESULT TICKETS REPORTED FOR SERIAL AC02949, AS DESCRIBED IN THIS COMPLAINT. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. THE ALINITY CI-SERIES OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS, TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. THE OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF DEPRESSED AND ERRATIC SAMPLE RESULTS. A SEARCH DID NOT IDENTIFY A NONCONFORMANCE OR POTENTIAL NONCONFORMANCE FOR COMPLAINT CAUSE AS RELATED TO THE CURRENT ISSUE. A REVIEW OF ALINITY C CLINICAL CHEMISTRY DATA IDENTIFIED NO ADVERSE TREND FOR THE ALINITY C AND NO SIMILAR ISSUES FOR DISCREPANT RESULTS AS DESCRIBED IN THIS COMPLAINT. NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE ACCOUNT OBSERVED FALSE DEPRESSED RESULTS ON MULTIPLE ASSAYS PROCESSED ON ALINITY C PROCESSING MODULE THAT REPEATED HIGHER. ON (B)(6) 2022 SID (B)(6) (B)(6) RACE/ETHNICITY NOT AVAILABLE) GENERATED SODIUM OF 110 MEQ/L, REPEATED 142 MEQ/L; CO2 OF 19 MEQ/L, REPEATED 23 MEQ/L. THE ACCOUNT USES REFERENCE RANGES: SODIUM OF 136-145 MEQ/L; CO OF 22-29 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633195 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male ALNTY C CO2 RGT LIST 07P72-20 LOT 60695UQ10