BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 17054349 · Received June 2, 2023

    Report

    Report Number
    3016438761-2023-00304
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 17, 2023
    Report Date
    July 12, 2023
    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

    UPON REVIEW OF THE RESULTS THROUGH ABBOTTLINK, THERE WERE SEVERAL MESSAGE CODES 3460 [ASPIRATION ERROR FOR SAMPLE AT (0). 0 = PIPETTING LOCATION] AND 3062 [RESIDUAL LIQUID DETECTED IN CUVETTE (0). 0 = CUVETTE NUMBER]. THE CUSTOMER PERFORMED RECOMMENDED TROUBLESHOOTING WHICH RESOLVED THE ISSUE. TRENDING REVIEW DETERMINED NO TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    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 STATED THAT FALSELY DECREASED ALINITY C RESULTS WERE REPORTED FOR A PATIENT (SAMPLE ID (B)(6)) AND QUESTIONED. THE CUSTOMER RETESTED THE SAME SAMPLE AND RESULTS WERE HIGHER. THE FOLLOWING DATA WAS PROVIDED. SODIUM: INITIAL RESULT OF 109 MEQ/L RETESTED AT 137 AND 137 MEQ/L. POTASSIUM: INITIAL RESULT OF 3.4 MEQ/L RETESTED AT 4.3 MEQ/L. CHLORIDE: INITIAL RESULT OF 76 MEQ/L RETESTED AT 97 MEQ/L. NORMAL REFERENCE RANGES: SODIUM: 136 - 145 MEQ/L. POTASSIUM: 3.5 - 5.1 MEQ/L. CHLORIDE: 98 - 107 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT FALSELY DECREASED ALINITY C RESULTS WERE REPORTED FOR A PATIENT (SAMPLE ID (B)(6)) AND QUESTIONED. THE CUSTOMER RETESTED THE SAME SAMPLE AND RESULTS WERE HIGHER. THE FOLLOWING DATA WAS PROVIDED. SODIUM: INITIAL RESULT OF 109 MEQ/L RETESTED AT 137 AND 137 MEQ/L. POTASSIUM: INITIAL RESULT OF 3.4 MEQ/L RETESTED AT 4.3 MEQ/L. CHLORIDE: INITIAL RESULT OF 76 MEQ/L RETESTED AT 97 MEQ/L. NORMAL REFERENCE RANGES: SODIUM: 136 - 145 MEQ/L. POTASSIUM: 3.5 - 5.1 MEQ/L. CHLORIDE: 98 - 107 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948904 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C ICT SAMPLE DILU, 07P53-20, UNKNOWN| ALNTY C ICT SAMPLE DILU, 07P53-20, UNKNOWN