BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 20046362 · Received August 23, 2024

    Report

    Report Number
    2939693-2024-00003
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 23, 2024
    Report Date
    November 8, 2024
    Manufacturer
    ABAXIS
    Product Code
    JJG
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    11 JUL 2024: ZOETIS/ABAXIS UNION CITY TECHNICAL SUPPORT RECEIVED A CALL FROM A LABORATORY PROFESSIONAL REPORTING INCORRECT PATIENT RANGE FORMATS ON THE PICCOLO XPRESS ANALYZER RESULT PRINTOUT. THE INSTRUMENT WAS RETURNED TO ZOETIS/ABAXIS UNION CITY, PRODUCT ASSURANCE, FOR INVESTIGATION. DURING TRIAGE, IT WAS DISCOVERED THAT THE SOFTWARE VERSION INSTALLED WAS 3.1.39, WHICH IS A VETSCAN 2-ONLY SOFTWARE VERSION. THERE HAS BEEN NO REPORTED PATIENT IMPACT. THE REPORTED ISSUE DID NOT CONTRIBUTE TO SERIOUS INJURY OR MEDICAL INTERVENTION. AS PART OF A PREVIOUS RISK ASSESSMENT ANALYSIS PERFORMED BY ZOETIS/ABAXIS UNION CITY QUALITY ON 2.7.24, THE SOURCE CODES FOR BOTH SOFTWARE VERSIONS (PICCOLO AND VETSCAN) WAS REVIEWED BOTH VISUALLY AND VIA AUTOMATED MEANS USING "COMPARE IT!" VERSION 4.2.2221. THE RISK ANALYSIS CONCLUDED THAT THE ALGORITHMS USED BY BOTH SOFTWARE VERSIONS ARE IDENTICAL, MEANING THAT THERE IS NO DIFFERENCE IN HOW THE RESULTS ARE CALCULATED BETWEEN THE VETSCAN AND PICCOLO SOFTWARE VERSIONS. A CAPA HAS BEEN INITIATED, AND A FOLLOW-UP WILL BE SUBMITTED PENDING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION (PER CAPA PR 2853346) WAS CONDUCTED ON THE PICCOLO XPRESS SOFTWARE. IT WAS DETERMINED THAT WHEN A FRONT PANEL (CONTAINING DEFAULT SOFTWARE) WAS REPLACED DURING THE REPAIR PROCESS, THE TECHNICIAN SELECTED THE INCORRECT SOFTWARE CD, WHICH WAS INSTALLED AND ACCEPTED ONTO THE INSTRUMENT. THE INCORRECT SOFTWARE VERSION INSTALLED WAS THE 3.1.39 VERSION. INTERNAL MANUFACTURING TESTING RECORDS WERE USED TO PULL AND REVIEW THE INSTRUMENT LOGS ON ALL MANUFACTURED AND REPAIRED PICCOLO XPRESS CHEMISTRY ANALYZERS FROM JAN 2020 TO AUG 2024 TO IDENTIFY THE SOFTWARE VERSION. A TOTAL OF SEVEN EXTERNAL PICCOLO XPRESS CHEMISTRY ANALYZERS WERE FOUND TO CONTAIN SOFTWARE VERSION 3.1.39 PER THE MANUFACTURING TEST RECORDS - FIVE IN THE UNITED STATES (U.S.), ONE IN THE UNITED KINGDOM (U.K.), AND ONE IN SAUDI ARABIA; FOUR OF THESE INSTRUMENTS WERE FOUND TO BE WITHIN THE FIELD AND REMEDIATED. ALL ANALYZERS CONTAINING SOFTWARE VERSION 3.1.39 HAD DEFAULT FRONT PANEL SOFTWARE WHEN THE SOFTWARE 3.1.39 VERSION WAS LOADED. THIS OCCURS WHEN THE FRONT PANEL IS REPLACED, OR THE COMPACT FLASH (CF) CARD IS REFORMATTED. THE RISK WAS ASSESSED PER DOCUMENT (B)(4), FAILURE MODE, AND EFFECTS ANALYSIS (FMEA) DOCUMENTS. A TOTAL OF 3,515 PICCOLO XPRESS CHEMISTRY ANALYZER INSTRUMENTS WERE SHIPPED TO CUSTOMERS FROM MAY 2020 TO AUG 2024. THE INCIDENT RATE FOR INSTRUMENTS SHIPPED TO CUSTOMERS WITH SOFTWARE VERSION 3.1.39 = 0.14%. THE PREVIOUS COMPLAINT REGARDING THE PICCOLO XPRESS CHEMISTRY ANALYZER WITH SOFTWARE 3.1.39 VERSION WAS REPORTED UNDER MEDICAL DEVICE REPORT 2939693-2023-00006 AND CONFIRMED TO HAVE THE SAME ROOT CAUSE AS SERIAL NUMBER (B)(6). ZOETIS/ ABAXIS INSTRUMENT MANUFACTURING HAS CHECKS IN PLACE FOR SOFTWARE VERIFICATION. A REVIEW OF THE COMPLAINT DATA SHOWED THAT NO FURTHER RELATED COMPLAINTS HAVE BEEN RECEIVED. A PLANNED TEMPORARY CHANGE (B)(4) WAS IMPLEMENTED TO INSPECT RETURNED INSTRUMENTS AFTER REPAIR, AND QUALITY ASSURANCE (QA) WILL REVIEW INSTRUMENT RECORDS FOR THE CORRECT SOFTWARE VERSION PRIOR TO RELEASE. ZOETIS/ABAXIS INSTRUMENT REPAIR AND QA REVIEW PROCEDURES WILL BE UPDATED TO PERMANENTLY REQUIRE QA TO REVIEW EACH RETURNED ANALYZER'S INSTRUMENT DEVICE RECORD. A QA SIGNATURE WILL BE REQUIRED TO RELEASE THE RETURNED INSTRUMENTS TO CUSTOMERS, AND A NEW QUALITY VERIFICATION STEP WILL CONFIRM THAT THE CORRECT SOFTWARE IS LOADED FOR EVERY INSTRUMENT REPAIRED. THE PHYSICAL SEPARATION OF THE MANUFACTURING AND REPAIR AREAS FOR VETERINARY AND HUMAN HEALTH ANALYZERS WILL BE EVALUATED, AND MEASURES WILL BE IMPLEMENTED TO ENSURE THE SEPARATE EXECUTION OF THE REPAIR AND MANUFACTURING PROCESSES. AN ENGINEERING CONTROL OF THE SOFTWARE (SW) CHECK PROGRAM WILL BE IMPLEMENTED IN ZOETIS/ABAXIS PRODUCTION AND REPAIR CENTERS AS PART OF THE REPAIR PROCESS TO READ AND VERIFY THE CORRECT SOFTWARE VERSION ON EACH INSTRUMENT MANUFACTURED OR REPAIRED. ALL REPAIR CENTERS WILL PRINT OUT THE 'ALL RESULTS' OPTION FROM THE ANALYZER AND ADD A QA SIGN-OFF FOR COMPLETED REPAIRS AND AN EFFECTIVENESS CHECK WILL BE CONDUCTED TO RECONCILE THE PICCOLO UNITS FOR SOFTWARE POST-IMPLEMENTATION. ZOETIS/ABAXIS WILL CONTINUE OUR POST-MARKET SURVEILLANCE PROGRAM, WHICH INVOLVES MONITORING PRODUCTS ON THE MARKET WORLDWIDE FOR PERFORMANCE AND SAFETY.

    Description of Event or Problem · 0

    11JUL2024: ABAXIS UNION CITY TECHNICAL SUPPPORT REICEVED A CALL FROM A LABORATORY PROFESSIONAL REPORTING THE PATIENT RANGE FORMATS WERE INCORRECT ON PICCOLO XPRESS ANALYZER RESULT PRINT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256942 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO ANALYZER JJG ABAXIS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown