BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 21447570 · Received February 24, 2025

    Report

    Report Number
    3016438761-2025-00117
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 10, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND DETERMINED THE LEAKING TUBING, PERISTALTIC HEAD (ROHS) (7-202464-01) WAS REPLACED, 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 PRE- OR POST THE CURRENT COMPLAINT WERE IDENTIFIED. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES DESCRIBED IN THIS COMPLAINT. ADDITIONALLY REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE TUBING, PERISTALTIC HEAD (ROHS) (7-202464-01) DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. 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 TUBING, PERISTALTIC HEAD (ROHS) AND TUBING, ICT PINCH VALVE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ALINITY CI PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE TUBING, PERISTALTIC HEAD (ROHS).

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE2 RESULTS WHICH QUESTIONED BY THE PHYSICIAN ON ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=452.9 UMOL/L. THE PATIENT WAS HOSPITALIZED DUE TO FALSELY ELEVATED ALINITY C CREATININE RESULT. THE BLOOD REDRAWN AND TESTED AT THE HOSPITAL. REDRAWN AND REPEATED=80.8 UMOL/L REANALYZED INITIAL SPECIMEN=81.3 UMOL/L THERE WAS NO UNNECESSARY TREATMENT GIVEN TO THE PATIENT DURING HOSPITALIZATION EXCEPT BLOOD DRAWN FOR RETESTING. THE PATIENT WAS DISCHARGED FROM HOSPITAL AFTER NORMAL CREATININE TEST RESULT. NO FURTHER HARM TO THE PATIENT MANAGEMENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE2 RESULTS WHICH QUESTIONED BY THE PHYSICIAN ON ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=452.9 UMOL/L . THE PATIENT WAS HOSPITALIZED DUE TO FALSELY ELEVATED ALINITY C CREATININE RESULT. THE BLOOD REDRAWN AND TESTED AT THE HOSPITAL. REDRAWN AND REPEATED=80.8 UMOL/L. REANALYZED INITIAL SPECIMEN=81.3 UMOL/L. THERE WAS NO UNNECESSARY TREATMENT GIVEN TO THE PATIENT DURING HOSPITALIZATION EXCEPT BLOOD DRAWN FOR RETESTING. THE PATIENT WAS DISCHARGED FROM HOSPITAL AFTER NORMAL CREATININE TEST RESULT. NO FURTHER HARM TO THE PATIENT MANAGEMENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402317 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALIN C CREATIN 3000T CN, 07P99-77, UNKNOWN| ALIN C CREATIN 3000T CN, 07P99-77, UNKNOWN