BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 17790220 · Received September 21, 2023

    Report

    Report Number
    3016438761-2023-00507
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 3, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT, ALINITY C SERIAL # (B)(6). THE FSR PERFORMED MULTIPLE TROUBLESHOOTING PROCEDURES INCLUDING REPLACEMENT OF THE PERISTALTIC HEAD TUBING (ROHS) (7-202464-01). SERVICE DETERMINED THE TUBING, PERISTALTIC HEAD (ROHS)_PART NUMBER 7-202464-01 WAS THE LIKELY CAUSE. REPLACEMENT OF THE PART RESOLVED THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6) .THERE WERE NO 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 ALINITY C PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6), WAS 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= (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT RESULTS ON THE ALINITY C ANALYZER FOR MULTIPLE ASSAYS AND MULTIPLE PATIENTS. THE RESULTS WERE NOT RELEASED UNLESS DESIGNATED BELOW. THE SAMPLES WERE REPEATED WITH EXPECTED RESULTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) : POTASSIUM INITIAL RESULT = 8.4 REPEAT RESULT = 3.6, CALCIUM INITIAL RESULT = 4.93 REPEAT RESULT = 2.35. (B)(6) : POTASSIUM INITIAL RESULT = 7.6 REPEAT RESULT = 4.4, CO2 INITIAL RESULT = 44 REPEAT RESULT = 27. (B)(6) : POTASSIUM INITIAL RESULT = 8.2 REPEAT RESULT = 4.9. (B)(6) : POTASSIUM INITIAL RESULT = 7.0 REPEAT RESULT = 4.3. (B)(6) : POTASSIUM INITIAL RESULT = 7.2 REPEAT RESULT = 4.6. (B)(6) : CO2 INITIAL RESULT = 33 REPEAT RESULT = 27. (B)(6) : POTASSIUM INITIAL RESULT = 8.8 REPEAT RESULT = 4.8. CALCIUM INITIAL RESULT = 4.58 REPEAT RESULT = 2.27. (B)(6) : POTASSIUM INITIAL RESULT = 9.5 REPEAT RESULT = 4.9. (B)(6) : POTASSIUM INITIAL RESULT = 7.4 REPEAT RESULT = 4.5. (B)(6) : POTASSIUM INITIAL RESULT = 7.2 REPEAT RESULT = 4.0. CALCIUM INITIAL RESULT = 4.86 REPEAT RESULT = 2.31. CO2 INITIAL RESULT = 36 REPEAT RESULT = 21. (B)(6) : CALCIUM INITIAL RESULT = 1.29 REPEAT RESULT = 2.31. (B)(6) : CO2 INITIAL RESULT = 40 REPEAT RESULT = 27. (B)(6) : RESULTS WERE RELEASED, CHLORIDE INITIAL RESULT = 148 REPEAT RESULT = 105. APPROXIMATE REFERENCE (NORMAL) RANGE FOR SODIUM: 136 TO 145 MMOL/L. APPROXIMATE REFERENCE (NORMAL) RANGE FOR POTASSIUM: 3.5 TO 5.1 MMOL/L. APPROXIMATE REFERENCE (NORMAL) RANGE FOR CHLORIDE: 98 TO 107 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT RESULTS ON THE ALINITY C ANALYZER FOR MULTIPLE ASSAYS AND MULTIPLE PATIENTS. THE RESULTS WERE NOT RELEASED UNLESS DESIGNATED BELOW. THE SAMPLES WERE REPEATED WITH EXPECTED RESULTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6): POTASSIUM INITIAL RESULT = 8.4 REPEAT RESULT = 3.6. CALCIUM INITIAL RESULT = 4.93 REPEAT RESULT = 2.35. (B)(6): POTASSIUM INITIAL RESULT = 7.6 REPEAT RESULT = 4.4. CO2 INITIAL RESULT = 44 REPEAT RESULT = 27. (B)(6): POTASSIUM INITIAL RESULT = 8.2 REPEAT RESULT = 4.9. (B)(6): POTASSIUM INITIAL RESULT = 7.0 REPEAT RESULT = 4.3. (B)(6): POTASSIUM INITIAL RESULT = 7.2 REPEAT RESULT = 4.6. (B)(6): CO2 INITIAL RESULT = 33 REPEAT RESULT = 27. (B)(6): POTASSIUM INITIAL RESULT = 8.8 REPEAT RESULT = 4.8. CALCIUM INITIAL RESULT = 4.58 REPEAT RESULT = 2.27. (B)(6): POTASSIUM INITIAL RESULT = 9.5 REPEAT RESULT = 4.9. (B)(6): POTASSIUM INITIAL RESULT = 7.4 REPEAT RESULT = 4.5. (B)(6): POTASSIUM INITIAL RESULT = 7.2 REPEAT RESULT = 4.0. CALCIUM INITIAL RESULT = 4.86 REPEAT RESULT = 2.31. CO2 INITIAL RESULT = 36 REPEAT RESULT = 21. (B)(6): CALCIUM INITIAL RESULT = 1.29 REPEAT RESULT = 2.31. (B)(6): CO2 INITIAL RESULT = 40 REPEAT RESULT = 27. (B)(6): RESULTS WERE RELEASED. CHLORIDE INITIAL RESULT = 148 REPEAT RESULT = 105. APPROXIMATE REFERENCE (NORMAL) RANGE FOR SODIUM: 136 TO 145 MMOL/L. APPROXIMATE REFERENCE (NORMAL) RANGE FOR POTASSIUM: 3.5 TO 5.1 MMOL/L. APPROXIMATE REFERENCE (NORMAL) RANGE FOR CHLORIDE: 98 TO 107 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594894 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown