BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY CI-SERIES LEVEL SENSOR, BULK SOLUTION

    MDR report key: 10326622 · Received July 27, 2020

    Report

    Report Number
    3002809144-2020-00733
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    July 5, 2020
    Report Date
    July 27, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3002809144-09/18/19-008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SID: (B)(6). ALL AVAILABLE PATIENT INFORMATION WERE INCLUDED, NO OTHER PATIENT INFORMATION WAS AVAILABLE. CORRECTION/REMOVAL NUMBER: 3002809144-09/18/19-008-C . FURTHER INVESTIGATION INTO THIS ISSUE FOUND THAT RESULTS COULD HAVE BEEN IMPACTED BY A DEFICIENCY OF THE ALINITY CI BULK SOLUTION LEVEL SENSOR, WHERE A CRACK COULD HAVE DEVELOPED FROM ENVIRONMENTAL STRESS. A PRODUCT CORRECTION LETTER HAS BEEN ISSUED TO ALL WORLDWIDE CUSTOMERS WITH INSTALLED ALINITY I PROCESSING MODULE AND/OR ALINITY C PROCESSING MODULE. THE LETTER INFORMS THE CUSTOMER THAT THE NEWLY RELEASED BULK SOLUTION LEVEL SENSOR (04S68-03) WILL NO LONGER BE AVAILABLE IN Q4 2019 AND TO CONTINUE TO USE THE BULK SOLUTION LEVEL SENSOR (04S68-02) WITH THE FOLLOWING INSTRUCTIONS: INSPECT THE PART FOR CRACKS PRIOR TO INSTALLATION. CONTINUE TO FOLLOW THE WEEKLY MAINTENANCE PROCEDURE AFTER INSTALLATION. THE LETTER ALSO PROVIDES TROUBLESHOOTING ACTIONS THAT SHOULD BE TAKEN IF ANY OF THE ERROR CODES ASSOCIATED WITH A CRACKED ALINITY CI-SERIES LEVEL SENSOR WERE RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TOTAL B-HCG RESULTS FOR SIX PATIENTS. THE FOLLOWING DATA WAS PROVIDED (>/=5.00 IU/L IS NEGATIVE, >/=25.00 IU/L IS POSITIVE): PATIENT 1 INITIAL RESULT, ON (B)(6) 2020, WAS 132,000 IU/L. PATIENT WAS RECOLLECTED ON (B)(6) 2020, RESULT WAS 14,800 IU/L. THE PHYSICIAN QUESTIONED THE RESULT AND SENT THE PATIENT FOR AN ULTRASOUND. BOTH SAMPLES WERE REPEATED ON ANOTHER ALINITY ANALYZER, SERIAL NUMBER (SN) (B)(4), THE RESULT FROM (B)(6) 2020 WAS 140,800 IU/L AND THE RESULT FROM (B)(6) 2020 WAS 149,000 IU/L. SAMPLE ID (B)(6) INITIAL RESULT, ON ALINITY I SN (B)(4), ON (B)(6) 2020, WAS 14,358, REPEATED ON ALINITY I SN (B)(4) WAS 130,329 IU/L. SAMPLE ID (B)(6) INITIAL RESULT, ON ALINITY I SN (B)(4), ON (B)(6) 2020, WAS 14,196, REPEATED ON ALINITY I SN (B)(4) WAS 71,751 IU/L. SAMPLE ID (B)(6) INITIAL RESULT, ON ALINITY I SN (B)(4), ON (B)(6) 2020, WAS 14,201, REPEATED ON ALINITY I SN (B)(4) WAS 34,924 IU/L. SAMPLE ID (B)(6) INITIAL RESULT, ON ALINITY I SN (B)(4), ON (B)(6) 2020, WAS 14,447, REPEATED ON ALINITY I SN (B)(4) WAS 138,109 IU/L. SAMPLE ID (B)(6) INITIAL RESULT, ON ALINITY I SN (B)(4), ON (B)(6) 2020, WAS 14,924, REPEATED ON ALINITY I SN (B)(4) WAS 95,221 IU/L. DURING SITE VISIT THE FIELD SERVICE REPRESENTATIVE PERFORMED MULTIPLE TROUBLESHOOTING STEPS AND ALSO REPLACED THE TRIGGER LEVEL SENSOR AS THE LEVEL SENSOR WAS CRACKED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793208 ALINITY CI-SERIES LEVEL SENSOR, BULK SOLUTION LEVEL SENSOR, BULK SOLUTION JJE ABBOTT GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1