BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 18742389 · Received February 20, 2024

    Report

    Report Number
    3016438761-2024-00102
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    February 10, 2024
    Report Date
    April 17, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). UPDATED SECTION B5: DESCRIBE EVENT OR PROBLEM. ADDITIONAL INFORMATION PROVIDED ON 16FEB2024: ON (B)(6) 2024 SID (B)(6) INITIAL=0.00 NG/L /REPEATED AFTER RE-CENTRIFUGED=1270 NG/L /REPEATED ON (B)(6) =1290 NG/L. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION D4: PRIMARY UDI NUMBER TO (B)(4). DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER ONSITE AND REPLACED THE PRE-TRIGGER CABS PLUNGER AND THE BULK SOLUTION TRANSFER PUMP. THE PARTS WERE CONSIDERED THE LIKELY CAUSE FOR THE FALSELY DEPRESSED RESULTS. THERE HAVE BEEN NO SUBSEQUENT TICKETS DOCUMENTED FOR INCONSISTENT PATIENT RESULTS SINCE THE REPLACEMENT OF THE LIKELY CAUSE PARTS. A REVIEW OF THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE REVIEW IDENTIFIED THREE ADDITIONAL DEMAND SERVICE TICKETS ASSOCIATED WITH PRE-TRIGGER DISPENSE ISSUES:(B)(6) (RECEIPT DATE 1/27/2024); (B)(6) (RECEIPT DATE 2/07/2024); AND (B)(6) (RECEIPT DATE 2/15/2024). A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE PRE-TRIGGER CABS PLUNGE OR THE BULK SOLUTION TRANSFER PUMP. THE ALINITY CI SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM AND ADDRESSES TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE PRE-TRIGGER CABS PLUNGE OR THE BULK SOLUTION TRANSFER PUMP.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: INITIAL RESULTS FROM (B)(6) /REPEATED ON (B)(6). SID (B)(6): MALE PATIENT: INITIAL=0,0 NG/L /REPEATED=2925 NG/L. SID (B)(6): FEMALE PATIENT: 0,0 NG/L /REPEATED=42,9 NG/L. LABORATORY REFERENCE RANGE: FEMALE=<16 NG/L; MALE= <35 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: INITIAL RESULTS FROM (B)(6) /REPEATED ON (B)(6) SID (B)(6) : MALE PATIENT: INITIAL=0.0 NG/L /REPEATED=2925 NG/L SID (B)(6) : FEMALE PATIENT: 0.0 NG/L /REPEATED=42,9 NG/L LABORATORY REFERENCE RANGE: FEMALE=<16 NG/L; MALE= <35 NG/L ADDITIONAL INFORMATION PROVIDED ON 16FEB2024: ON (B)(6) 2024 SID (B)(6) -301 INITIAL=0.00 NG/L /REPEATED AFTER RE-CENTRIFUGED=1270 NG/L /REPEATED ON (B)(6) =1290 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: INITIAL RESULTS FROM (B)(6) /REPEATED ON (B)(6). SID (B)(6): MALE PATIENT: INITIAL=0.0 NG/L /REPEATED=2925 NG/L. SID (B)(6): FEMALE PATIENT: 0.0 NG/L /REPEATED=42,9 NG/L. LABORATORY REFERENCE RANGE: FEMALE=<16 NG/L; MALE= <35 NG/L. ADDITIONAL INFORMATION PROVIDED ON 16FEB2024: ON (B)(6) 2024 SID (B)(6) -301 INITIAL=0.00 NG/L /REPEATED AFTER RE-CENTRIFUGED=1270 NG/L /REPEATED ON (B)(6) =1290 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426446 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALINITY I TROPONIN RGT, 08P13-34, (B)(6) | ALINITY I TROPONIN RGT, 08P13-34, (B)(6) | ALINITY I TROPONIN RGT, 08P13-34, (B)(6)