BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 21324794 · Received February 6, 2025

    Report

    Report Number
    3016438761-2025-00083
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 23, 2025
    Report Date
    February 24, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) REVIEWED THE MODULE LOGS AND DETERMINED THE TUBING, PERISTALTIC HEAD (ROHS) (7-202464-01) THE LIKELY CAUSE OF THE ISSUE. THE PART WAS REPLACED, AND THE ISSUE WAS RESOLVED. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT RESULTS. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE CLINICAL CHEMISTRY SYSTEMS DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE ALINITY C SYSTEM, AND THE TUBING, PERISTALTIC HEAD (ROHS) (7-202464-01) OR DISCREPANT RESULTS AS DESCRIBED IN THIS COMPLAINT. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND NO NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE SERIAL NUMBER (B)(6) OR THE TUBING, PERISTALTIC HEAD (ROHS) (7-202464-01 WERE IDENTIFIED.

    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 SID (B)(6) AND SID (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED IMPRECISE MAGNESIUM AND CALCIUM RESULTS ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) FOR TWO PATIENTS. THE PATIENTS WERE REPEATED WITH EXPECTED RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID(B)(6), INITIAL MAGNESIUM RESULT PROCESSED ON (B)(6)2025 = 2.75 MMOL/L REPEAT RESULT PROCESSED ON (B)(6) 2025 = 0.81 MMOL/L. SID (B)(6), INITIAL CALCIUM RESULT PROCESSED ON (B)(6) 2025 = 3.3 MG/DL REPEATED THE SAME DAY = 10.1 MG/DL. CALCIUM REFERENCE RANGE = 8.4 TO 10.2 MG/DL. MAGNESIUM REFERENCE RANGE = 0.66 TO 1.07 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED IMPRECISE MAGNESIUM AND CALCIUM RESULTS ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) FOR TWO PATIENTS. THE PATIENTS WERE REPEATED WITH EXPECTED RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL MAGNESIUM RESULT PROCESSED ON (B)(6) 2025 = 2.75 MMOL/L REPEAT RESULT PROCESSED ON (B)(6) 2025 = 0.81 MMOL/L. SID (B)(6) INITIAL CALCIUM RESULT PROCESSED ON (B)(6) 2025 = 3.3 MG/DL REPEATED THE SAME DAY = 10.1 MG/DL. CALCIUM REFERENCE RANGE = 8.4 TO 10.2 MG/DL MAGNESIUM REFERENCE RANGE = 0.66 TO 1.07 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311731 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALN C CALCIUM RGT 4000T, 07P57-20, 04892UN24| ALN C CALCIUM RGT 4000T, 07P57-20, 04892UN24| ALNTY C MAG (720T), 08P19-25, 68277UD00| ALNTY C MAG (720T), 08P19-25, 68277UD00| TUBING, PERISTALTIC HEAD (ROHS), 7-202464-01, UNKN| TUBING, PERISTALTIC HEAD (ROHS), 7-202464-01, UNKN