BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 19354930 · Received May 20, 2024

    Report

    Report Number
    3016438761-2024-00303
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE MODULE AND RESOLVED THE ISSUE BY REPLACING THE PERISTALTIC HEAD TUBING (ROHS) (7-202464-01) AND CLEANING THE CUVETTES. NO ADDITIONAL RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS PERFORMED. THE PERISTALTIC HEAD TUBING (ROHS) (7-202464-01) WAS DETERMINED TO BE LIKELY CAUSE OF THE RESULT ISSUES. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6). A REVIEW OF TRACKING AND TRENDING OF THE ALINITY C PROCESSING MODULE AND THE PERISTALTIC HEAD TUBING (ROHS) (7-202464-01) DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES FOR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) OR THE PERISTALTIC HEAD TUBING (ROHS) (7-202464-01) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SID: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6). THE SAMPLES WERE REPEATED ON ALINITY C SERIAL NUMBER (B)(6) WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: ALL RESULTS PROCESSED ON 08MAY2024: SID (B)(6) RAN ON (B)(6) CA =14.1 MG/DL REPEAT SAME SAMPLE ON (B)96) = 9.0 MG /DL. SID (B)(6) RAN ON (B)(6) CO2 = 45 MMOL /L REPEAT SAME SAMPLE ON (B)(6) CO2 = 19 MMOL/L. SID (B)(6) RAN ON (B)(6) ON 5/8 @ 0830 SODIUM = 173 MMOL/L REPEAT SAME SAMPLE ON (B)(6) NA =138 MMOL /L. REFERENCE RANGES: SODIUM 136-145. CALCIUM 8.5-10.5. CO2 22-29 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6). THE SAMPLES WERE REPEATED ON ALINITY C SERIAL NUMBER (B)(6) WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: ALL RESULTS PROCESSED ON 08MAY2024: SID (B)(6) RAN ON (B)(6) CA =14.1 MG/DL REPEAT SAME SAMPLE ON (B)(6) = 9.0 MG /DL. SID (B)(6) RAN ON (B)(6) CO2 = 45 MMOL /L REPEAT SAME SAMPLE ON (B)(6) CO2 = 19 MMOL/L. SID (B)(6) RAN ON (B)(6) ON 5/8 @ 0830 = 173 MMOL/L REPEAT SAME SAMPLE ON (B)(6) NA =138 MMOL /L. REFERENCE RANGES: SODIUM 136-145. CALCIUM 8.5-10.5. CO2 22-29 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569759 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TUBING, PERISTALTIC HEAD (ROHS), 7-202464-01, UNKN| TUBING, PERISTALTIC HEAD (ROHS), 7-202464-01, UNKN