BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 17905621 · Received October 10, 2023

    Report

    Report Number
    3016438761-2023-00539
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 16, 2023
    Report Date
    October 10, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE SYRINGE LEAKING AND THE R1 REAGENT PROBE TUBING KINKED. THE FSR REPLACED THE PARTS, ALNTY CSERIES 1 ML SYR (LIST NUMBER 09D41-03) AND ALNTY C RGT PR TB (04S50-01), WHICH RESOLVED THE ISSUE. A REVIEW OF THE ALINITY CI PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY WAS PERFORMED, AND NO ADDITIONAL ERRATIC RESULTS POST THE CURRENT COMPLAINT WERE IDENTIFIED. A REVIEW OF TRACKING AND TRENDING OF THE ALINITY C PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ALNTY CSERIES 1 ML SYR AND ALNTY C RGT PR TB. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. THE ALINITY CI-SERIES OPERATIONS MANUAL AND ALINITY C SERVICE DOCUMENTATION PROVIDE ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS AND THE REMOVAL, REPLACEMENT, AND VERIFICATION OF PART NUMBER ALNTY CSERIES 1 ML SYR AND PROBE TUBING. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ALINITY CI PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE ALNTY CSERIES 1 ML SYR.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS FOR MULTIPLE PARAMETERS GENERATED FROM ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ONE PATIENT: INITIAL CALCIUM= OVER 4.5 MMOL/L /REPEATED ON ANOTHER ANALYZER WITHIN EXPECTED RANGE (NO ACTUAL RESULTS PROVIDED) ON (B)(6) 2023 SECOND PATIENT: SID (B)(6) INITIAL CREATININE=267 UMOL/L /REPEATED ON AC04702=99 UMOL/L. AKI (ACUTE KIDNEY INJURY) =2 /REPEATED ON AC04702 =0. LABORATORY REFERENCE RANGE FOR CREATININE=49 TO 90 UMOL/L; AKI NORMAL RANGE=0; CRITICAL RANGE=2 AND 3. THE CUSTOMER PROVIDED ACUTE KIDNEY INJURY (AKI)SCORE THAT IS BASED ON SERUM CREATININE AND URINE OUTPUT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335791 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C CALCIUM RGT 150, 07P57-30, (B)(6)