BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 13433773 · Received February 2, 2022

    Report

    Report Number
    3016438761-2022-00053
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 11, 2022
    Report Date
    March 9, 2022
    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

    MULTIPLE PATIENTS INVOLVED. REFER TO SUMMARY OF SIDS AND ASSOCIATED TEST RESULTS. NO PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER OBSERVED RESIDUAL FLUID IN THE CUVETTES. THE FIELD SERVICE REPRESENTATIVE (FSR) RESOLVED THE ISSUE BY REPLACING THE HIGH CONCENTRATION WASTE PERISTALTIC PUMP TUBING (PART NUMBER 7-202464-01 TUBING, PERISTALTIC HEAD (ROHS)) AND MANUALLY CLEANING THE CUVETTES. WHICH RESOLVED THE ISSUE. A REVIEW OF SERVICE HISTORY FOR THE ALINITY C-SERIES PROCESSING MODULE, SERIAL NUMBER (B)(6) REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT RESULTS, NOR DID IT IDENTIFY ANY CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE TUBING, PERISTALTIC HEAD (ROHS) PART NUMBER 7-202464-01 DID NOT IDENTIFY ANY TRENDS. REVIEW OF TRACKING AND TRENDING FOR CLINICAL CHEMISTRY SYSTEMS DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE INSTRUMENT PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE TUBING, PERISTALTIC HEAD (ROHS) PART NUMBER 7-202464-01 OR THE ALINITY C-SERIES PROCESSING MODULE, SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED SODIUM RESULTS FOR TWO PATIENTS. THE FOLLOWING WAS PROVIDED: SID (B)(6) INITIAL: 119 MMOL/L (NOT REPORTED OUT OF LAB), 136 MMOL/L (CONSIDERED BY LAB AS REAL RESULT). SID (B)(6) INITIAL: 112 MMOL/L (NOT REPORTED OUT OF LAB), 140 MMOL/L (CONSIDERED BY LAB AS REAL RESULT). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452653 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown