BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 21750697 · Received April 2, 2025

    Report

    Report Number
    3016438761-2025-00202
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 16, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. SECTION A1 PATIENT IDENTIFIER SIDS: (B)(6).

    Additional Manufacturer Narrative · 0

    TROUBLESHOOTING PERFORMED BY THE CUSTOMER INCLUDED CUVETTE DRY TIP REPLACEMENT WHICH WAS DETERMINED TO BE THE LIKELY CAUSE. THE CUSTOMER CONFIRMED THERE HAS NOT BEEN ANY FURTHER ISSUES SINCE THIS TROUBLESHOOTING WAS COMPLETED. A REVIEW OF TICKETS IDENTIFIED NO CONTRIBUTING FACTORS TO THIS COMPLAINT. A TREND REVIEW FOUND NO TRENDS REQUIRING FURTHER INVESTIGATION. A REVIEW OF HISTORICAL DATA WITH THIS COMPLAINT REVEALED NO TRENDS, SYSTEMIC ISSUES, OR NONCONFORMANCES. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ERROR OCCURRED (RESIDUAL LIQUID DETECTED IN CUVETTE IN DIFFERENT POSITIONS) WHILE PROCESSING SAMPLES ON THE ALINITY C PROCESSING MODULE. A CUVETTE WASH PROCEDURE WAS NOT PERFORMED AS INSTRUCTED BY CUSTOMER SUPPORT. THE CUSTOMER PROCEEDED TO PROCESS SAMPLES GENERATING MANY INCORRECT RESULTS. THE FOLLOWING RESULTS WERE PROVIDED FROM (B)(6) 2025: SID (B)(6) POTASSIUM = 9.959 / 4.8; SODIUM = >200 / >200 / 145 / 143. SID (B)(6) CALCIUM = 4.55 / 2.4; SODIUM = >200 / 143. SID (B)(6) SODIUM = 193.2 / 142. SID (B)(6) SODIUM = 198 / 144; CALCIUM = 5.3 / 2.4 MMOL/L. SID (B)(6) POTASSIUM = 8.076 / 3.9; SODIUM = >200 / 145. SID (B)(6) POTASSIUM = 7.568 / 4.8; SODIUM = >200 / 143. SID (B)(6) SODIUM = 183.7 / 139. SID (B)(6) POTASSIUM =>10 / 4.6. SID (B)(6) POTASSIUM = >10 / 4.6; SODIUM = >200 / 138. SID (B)(6) SODIUM = >200 / 144. SID (B)(6) SODIUM = >200 / 134. SID (B)(6) SODIUM = >200 / 147. SID (B)(6) SODIUM = >200 / 139; CALCIUM = >6 / 2.6 MMOL/L. SID (B)(6) SODIUM = >200 / 144. SID (B)(6) SODIUM = >200 / 144. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ERROR OCCURRED (RESIDUAL LIQUID DETECTED IN CUVETTE IN DIFFERENT POSITIONS) WHILE PROCESSING SAMPLES ON THE ALINITY C PROCESSING MODULE. A CUVETTE WASH PROCEDURE WAS NOT PERFORMED AS INSTRUCTED BY CUSTOMER SUPPORT. THE CUSTOMER PROCEEDED TO PROCESS SAMPLES GENERATING MANY INCORRECT RESULTS. THE FOLLOWING RESULTS WERE PROVIDED FROM (B)(6) 2025: SID (B)(6) POTASSIUM = 9.959 / 4.8; SODIUM = >200 / >200 / 145 / 143. SID (B)(6) CALCIUM = 4.55 / 2.4; SODIUM = >200 / 143. SID (B)(6) SODIUM = 193.2 / 142. SID (B)(6) SODIUM = 198 / 144; CALCIUM = 5.3 / 2.4 MMOL/L. SID (B)(6) POTASSIUM = 8.076 / 3.9; SODIUM = >200 / 145. SID (B)(6) POTASSIUM = 7.568 / 4.8; SODIUM = >200 / 143. SID (B)(6) SODIUM = 183.7 / 139. SID (B)(6) POTASSIUM =>10 / 4.6. SID (B)(6) POTASSIUM = >10 / 4.6; SODIUM = >200 / 138. SID (B)(6) SODIUM = >200 / 144. SID (B)(6) SODIUM = >200 / 134. SID (B)(6) SODIUM = >200 / 147. SID (B)(6) SODIUM = >200 / 139 ; CALCIUM = >6 / 2.6 MMOL/L. SID (B)(6) SODIUM = >200 / 144. SID (B)(6) SODIUM = >200 / 144. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371318 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown