BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 17738579 · Received September 13, 2023

    Report

    Report Number
    3016438761-2023-00492
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 10, 2023
    Report Date
    September 29, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

    THE SERVICE REPRESENTATIVE REVIEWED MESSAGE HISTORY AND NOTED MULTIPLE OCCURRENCES OF MESSAGE CODE 0310 UNABLE TO PROCESS TEST. RACK REMOVED BEFORE ACCESS WAS GRANTED ON THE DAY OF THE INCIDENT, INCLUDING AN OCCURRENCE ON 08AUG2023. NO ADDITIONAL TROUBLESHOOTING OR PART REPLACEMENT WAS PERFORMED. A REVIEW OF THE ANALYZER SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF OCCURRENCE AND NO SUBSEQUENT TICKETS RELATED TO BAR CODE MISREADS HAVE OCCURRED. THE ALINITY I ANALYZER, LIST NUMBER 03R65-01, WAS CONSIDERED THE LIKELY CAUSE FOR THE ISSUE. A REVIEW OF THE (B)(6) RESULT LOG INDICATES TWO SEPARATE RUNS FOR SID (B)(6); THERE WAS NO EVIDENCE OF RESULTS ASSOCIATED WITH SID (B)(6) IN THE RESULT LOG. A SPECIFIC CAUSE FOR THE SAMPLE MISIDENTIFICATION WAS NOT IDENTIFIED. A 12-MONTH SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED NO COMPLAINTS OF A BARCODE MISREAD ASSOCIATED WITH THE ALINITY I PROCESSING MODULE. THE CURRENT COMPLAINT IS THE SOLE COMPLAINT RELATED TO A SAMPLE BARCODE MISIDENTIFICATION WITH THE ALINITY I SYSTEM. THE ALINITY CI SERIES OPERATIONS MANUAL ALSO ADDRESSES ERROR CODE 0310 UNABLE TO PROCESS TEST. RACK REMOVED BEFORE ACCESS WAS GRANTED. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED INCORRECT SID (B)(6), SCANNED ON DIFFERENT PATIENT SPECIMEN DOES NOT BELONGS WITH THIS SID FROM ALINITY I PROCESSING MODULE. THE CUSTOMER STATED RACK E1614/1 ALINITY I PROCESSING MODULE READ SID (B)(6). AND ACCESSION NUMBER (B)(6) ON WRONG PATIENT SPECIMEN. THE CUSTOMER UNABLE TO PROVIDE CORRECT SID FOR THAT PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6). VITAMIN B12=167 PG/ML; VITA D25OH=13.1 NG/ML; FREE T3=2.66 PG/ML; TSH=2.35 UIU/ML; FREE T4=0.85 NG/DL. THE CUSTOMER REPEATED MANUALLY SID (B)(6) DUE TO DELTA FLAG ON VITAMIN D AND VITAMIN B12. THE RESULTS PROVIDED FROM MANUAL RUN AS BELOW: SID (B)(6). VITAMIN B12. 2000 PG/ML; VITA D25OH 154.2 NG/ML /REPEATED. 154.2 NG/ML; TSH=1.27 UIU/ML; FT3=2.91 PG/ML; FT4=0.85 NG/DL. THESE MANUALLY REPEATED RESULTS MATCHED WITH PATIENT HISTORY. THE INCORRECT VITAMIN B12 AND VITAMIN D RESULTS REPORTED TO PATIENT DUE TO AUTO RELEASED FROM LIS. THE CUSTOMER CORRECTED INCORRECT RESULTS. THERE IS NO TREATMENT GIVEN DUE TO INCORRECT RESULTS. NO FURTHER IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED INCORRECT SID (B)(6) SCANNED ON DIFFERENT PATIENT SPECIMEN DOES NOT BELONGS WITH THIS SID FROM ALINITY I PROCESSING MODULE. THE CUSTOMER STATED RACK E1614/1 ALINITY I PROCESSING MODULE READ SID (B)(6) AND ACCESSION NUMBER (B)(6) ON WRONG PATIENT SPECIMEN. THE CUSTOMER UNABLE TO PROVIDE CORRECT SID FOR THAT PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) VITAMIN B12=167 PG/ML; VITA D25OH=13.1 NG/ML; FREE T3=2.66 PG/ML; TSH=2.35 UIU/ML; FREE T4=0.85 NG/DL. THE CUSTOMER REPEATED MANUALLY SID (B)(6) DUE TO DELTA FLAG ON VITAMIN D AND VITAMIN B12. THE RESULTS PROVIDED FROM MANUAL RUN AS BELOW: SID (B)(6) VITAMIN B12=> 2000 PG/ML; VITA D25OH=> 154.2 NG/ML /REPEATED=> 154.2 NG/ML; TSH=1.27 UIU/ML; FT3=2.91 PG/ML; FT4=0.85 NG/DL. THESE MANUALLY REPEATED RESULTS MATCHED WITH PATIENT HISTORY. THE INCORRECT VITAMIN B12 AND VITAMIN D RESULTS REPORTED TO PATIENT DUE TO AUTO RELEASED FROM LIS. THE CUSTOMER CORRECTED INCORRECT RESULTS. THERE IS NO TREATMENT GIVEN DUE TO INCORRECT RESULTS. NO FURTHER IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747680 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown