BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY CI-SERIES SYSTEM CONTROL MODULE

    MDR report key: 19619433 · Received June 26, 2024

    Report

    Report Number
    3016438761-2024-00377
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 11, 2024
    Report Date
    August 7, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137410
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 - CONCOMITANT PRODUCT - UPDATED TO INCLUDE ALNT CI SW V3.5.3, 04V20-26. THE COMPLAINT INVESTIGATION FOR INCORRECT TRANSMISSION OF RESULTS FROM THE ALINITY CI-SERIES SYSTEM CONTROL AFTER A SOFTWARE UPDATE ON THE ALINITY CI-SERIES SYSTEM CONTROL MODULE, SERIAL NUMBER (B)(6), OPERATING AT SOFTWARE V3.5.3, INCLUDED A REVIEW OF COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. THE ISSUE WAS RESOLVED AFTER CHANGING NUMBER FORMAT TO ¿NONE AND PERIOD". NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A1 - PATIENT IDENTIFIER - (B)(6) ( A TOTAL OF 10 PATIENTS) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INCORRECT TRANSMISSION OF RESULTS FROM THE ALINITY CI-SERIES SYSTEM CONTROL AFTER A SOFTWARE UPDATE (VERSION 3.5.3). THE CUSTOMER STATED THE OTHER ALINITY ON THE OLDER VERSION SOFTWARE WAS REPORTING NORMALLY. THE CUSTOMER REPORTED THAT ONLY ONE SAMPLE NEEDED TO BE CORRECTED. ALL OTHER SAMPLES WERE NOT RELEASED. THE FOLLOWING DATA WAS PROVIDED: PATIENT REFERENCE RANGE FOR FERRITIN: 10-120 UG/L ALL FERRITIN SAMPLES WERE >1675 BUT TRANSMITTED TO >1 IN THE SUNQUEST LIS. SAMPLE ID (B)(6) WAS THE ONLY SAMPLE RELEASE TO DOCTOR THAT NEEDED TO BE CORRECTED. DOCTOR DID NOT TREAT PATIENT BASED ON THIS RESULT. THE OTHER SAMPLE IDS THAT DID NOT GET RELEASED WERE: (B)(6). PATIENT REFERENCE RANGE FOR B12: 213-816 PG/ML SAMPLE ID (B)(6): ALINITY RESULT = 1374 PG/ML; SUNQUEST LIS RESULT = <148 PG/ML; SAMPLE ID (B)(6): ALINITY RESULT = 1192 PG/ML; SUNQUEST LIS RESULT = <148 PG/ML. PATIENT REFERENCE RANGE ALKALINE PHOSPHATASE: 32-92 U/L. SAMPLE ID (B)(6): ALINITY RESULT = >1650 U/L; SUNQUEST LIS RESULT = <9. THE FIELD SERVICE ENGINEER HAD THE CUSTOMER CHANGE THE NUMERICAL FORMAT AND THE ISSUE WAS RESOLVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INCORRECT TRANSMISSION OF RESULTS FROM THE ALINITY CI-SERIES SYSTEM CONTROL AFTER A SOFTWARE UPDATE (VERSION 3.5.3). THE CUSTOMER STATED THE OTHER ALINITY ON THE OLDER VERSION SOFTWARE WAS REPORTING NORMALLY. THE CUSTOMER REPORTED THAT ONLY ONE SAMPLE NEEDED TO BE CORRECTED. ALL OTHER SAMPLES WERE NOT RELEASED. THE FOLLOWING DATA WAS PROVIDED: PATIENT REFERENCE RANGE FOR FERRITIN: 10-120 UG/L ALL FERRITIN SAMPLES WERE >1675 BUT TRANSMITTED TO >1 IN THE SUNQUEST LIS. SAMPLE ID (B)(6) WAS THE ONLY SAMPLE RELEASE TO DOCTOR THAT NEEDED TO BE CORRECTED. DOCTOR DID NOT TREAT PATIENT BASED ON THIS RESULT. THE OTHER SAMPLE IDS THAT DID NOT GET RELEASED WERE: (B)(6) PATIENT REFERENCE RANGE FOR B12: 213-816 PG/ML SAMPLE ID (B)(6): ALINITY RESULT = 1374 PG/ML; SUNQUEST LIS RESULT = <148 PG/ML SAMPLE ID (B)(6): ALINITY RESULT = 1192 PG/ML; SUNQUEST LIS RESULT = <148 PG/ML PATIENT REFERENCE RANGE ALKALINE PHOSPHATASE: 32-92 U/L SAMPLE ID (B)(6): ALINITY RESULT = >1650 U/L; SUNQUEST LIS RESULT = <9 THE FIELD SERVICE ENGINEER HAD THE CUSTOMER CHANGE THE NUMERICAL FORMAT AND THE ISSUE WAS RESOLVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673895 ALINITY CI-SERIES SYSTEM CONTROL MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNT CI SW V3.5.3, 04V20-26,