BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 18723178 · Received February 16, 2024

    Report

    Report Number
    3016438761-2024-00093
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 30, 2024
    Report Date
    April 10, 2024
    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

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

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR IMPRECISE RESULTS WHEN USING ALINITY C ICT SAMPLE DILUENT LN 7P53-20 ON ALINITY C SERIAL NUMBER (B)(6) INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE SAMPLE WAS RETESTED USING THE SAME LOT OF REAGENT AND GAVE ACCEPTABLE RESULTS. IN ADDITION, THE QUALITY CONTROLS WERE WITHIN RANGE AT THE TIME OF THE INCIDENT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND THE COMPLAINT INVESTIGATION COMPLETED, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY C ICT SAMPLE DILUENT LN 7P53-20, ON THE ALINITY C ANALYZER, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS ON THE ALINITY C PROCESSING MODULE. NO INCORRECT RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER IS RUNNING SAMPLES IN DUPLICATE AND THE RESULTS ARE IMPRECISE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON (B)(6) 2024 RESULTS = 117, 141, 131, 141, 142, 142 MMOL/L SID (B)(6) DATA PROVIDED (B)(6) 2024 RESULTS = 135 AND 118 REPEAT ON ANOTHER ANALYZER = 136 REFERENCE RANGE FOR SODIUM = 136-145 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS ON THE ALINITY C PROCESSING MODULE. NO INCORRECT RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER IS RUNNING SAMPLES IN DUPLICATE AND THE RESULTS ARE IMPRECISE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON (B)(6) 2024 RESULTS = 117, 141, 131, 141, 142, 142 MMOL/L SID (B)(6) DATA PROVIDED (B)(6) 2024 RESULTS = 135 AND 118 REPEAT ON ANOTHER ANALYZER = 136. REFERENCE RANGE FOR SODIUM = 136-145 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509135 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

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