BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 10268114 · Received July 13, 2020

    Report

    Report Number
    2939693-2020-00062
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    September 26, 2018
    Report Date
    July 2, 2021
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF A THREE-YEAR RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE QUALITY IMPROVEMENT PROCESS, CALLS WERE IDENTIFIED IN WHICH THE CUSTOMER EXPERIENCED BURNING ODOR AND/OR SMOKE. THERE WERE NO INJURIES RELATED TO THE CUSTOMER COMPLAINTS RECEIVED, BASED ON THE POTENTIAL OF BURNING SMELL/SMOKE TO LEAD TO A POTENTIAL INJURY. BASED ON MDR REGULATIONS, ABAXIS REPORTED THESE EVENTS DUE TO: THE LIKELIHOOD OF THIS MALFUNCTION TO LEAD TO AN ADVERSE EVENT, ALTHOUGH THERE WAS NO EVIDENCE OR REPORTS OF ASSOCIATED ADVERSE EVENTS. MINIMAL DETAILED DOCUMENTATION RELATED TO THE LIKELIHOOD AND CAUSE OF BURNING ODOR AND SMOKE. AS PART OF AN INVESTIGATION REGARDING THE OVERALL REPORTED MALFUNCTION OF A BURNING ODOR AND/OR SMOKING, RISK ASSESSMENT, AND MAUDE DATABASE SEARCH, ZOETIS HAS CONCLUDED THAT THE BURNING ODOR/SMOKE OVERHEATING COMPLAINTS ARE A LOW INJURY RISK FOR THE USER OR PATIENT. THE IDENTIFIED MALFUNCTIONS HAVE NOT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY NOR DOES THE DATA SUGGEST THAT THE DEVICE OR A SIMILAR DEVICE MARKETED WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO REOCCUR. ZOETIS WILL CONTINUE TO MONITOR COMPLAINTS FOR BURNING ODOR/SMOKING/OVERHEATING TO DETERMINE IF ANY NEW INFORMATION IS OBTAINED AND ANY CHANGE TO THE RISKS FOR PATIENTS OR USERS OF THE PICCOLO XPRESS ANALYZER. IF NEW INFORMATION IS OBTAINED, NEW CAUSES WHERE RISK HAS NOT BEEN EVALUATED, POTENTIAL OF SERIOUS INJURY REPORTED OR IDENTIFIED, THE SITE WILL FOLLOW THE REQUIRED PROCESS FOR MDR REPORTING AND TIMELINESS.

    Additional Manufacturer Narrative · 1

    ON 26-SEP-2018, ABAXIS RECEIVED A CALL FROM THE CUSTOMER LAB REPORTING AN ISSUE WITH ANALYZER SN: (B)(4) STATING THAT THE DEVICE DISPLAYED A "4057 MOTOR SPEED" ERROR AND WAS EMITTING SMOKE. NO FIRE OR INJURY WAS REPORTED. THE CUSTOMER SENT THE DEVICE IN FOR REPAIR. DURING EVALUATION OF THE DEVICE, THE REPORTED PROBLEM WAS REPLICATED. THE DEVICE'S BALL LOCK PIN BEARING WAS NOTED TO GET STUCK AND THE GLOBAL DELAY FAILED DURING ABAXIS REPAIR SYSTEM TESTING. THE SPINDLE MOTOR, BALL LOCK PIN, OPTIC ASSEMBLY AND FAN FILTER WERE REPLACED TO RESOLVE THE REPORTED PROBLEM. THE DEVICE WAS CLEANED, CALIBRATED, PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER SITE WHERE IT REMAINS. NO FURTHER ACTIONS WERE REQUIRED. THIS MDR IS BEING SUBMITTED AS A RESULT OF A THREE (3) YEAR RETROSPECTIVE REVIEW OF CLOSED COMPLAINTS ABAXIS PERFORMED AS PART OF ITS COMMITMENT TO CORRECT THE FDA-483 OBSERVATIONS RECEIVED ON AUGUST 22, 2019. THERE HAS BEEN NO REOCCURRENCE REGARDING THE ISSUE OF SMOKING WITH THIS DEVICE POST REPAIRS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED A 4057 MOTOR SPEED ERROR AND EMITTED SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729147 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO ANALYZER JJG ABAXIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1