BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABAXIS, INC.

    MDR report key: 10176915 · Received June 19, 2020

    Report

    Report Number
    2939693-2020-00059
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    August 27, 2018
    Report Date
    July 2, 2021
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    UDI-DI
    EABA110000001
    PMA / PMN Number
    K934592
    Adverse Event
    Yes
    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: 1) THE LIKELIHOOD OF THIS MALFUNCTION TO LEAD TO AN ADVERSE EVENT, ALTHOUGH THERE WAS NO EVIDENCE OR REPORTS OF ASSOCIATED ADVERSE EVENTS. 2) 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 (B)(6) 2018, ABAXIS RECEIVED A CALL FROM THE CUSTOMER LAB REPORTING AN ISSUE WITH ANALYZER SN: (B)(4) STATING THAT THE DEVICE WAS DISPLAYING A "4035 SPINDLE MOTOR" ERROR, A "407F MOTOR SPEED" ERROR AND EMITTING A BURNING SMELL. NO FIRE OR INJURY WAS REPORTED. THE CUSTOMER POWERED OFF AND UNPLUGGED THE DEVCE. THE CUSTOMER SENT THE DEVICE IN FOR REPAIR. DURING EVALUATION OF THE DEVICE, THE "407F MOTOR SPEED" ERROR WAS CONFIRMED. THE BURNING SMELL REPORTED BY THE CUSTOMER WAS ALSO CONFIRMED. THE BALL LOCK PIN LOOKED FINE, BUT BLOOD SPLATTER WAS FOUND ON THE OPTICS HOUSING. THE SPINDLE MOTOR AND THE FAN FILTER WERE REPLACED.. THE DEVICE WAS NOT SHIPPED BACK TO THE CUSTOMER AND REMAINS INACTIVE AT ABAXIS. THE CUSTOMER WAS SHIPPED A NEW DEVICE TO RESOLVE THE REPORTED PROBLEM. NO FURTHER ACTIONS WERE TAKEN. 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-(B)(4)OBSERVATIONS RECEIVED ON AUGUST 22, 2019.

    Description of Event or Problem · 1

    THE CUSTOMER LAB REPORTED THAT THE DEVICE WAS DISPLAYIG A "4035 SPINDLE MOTOR" ERROR, A "407FMOTOR SPEED" ERROR AND EMITTING A BURNING SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638100 ABAXIS, INC. PICCOLO ANALYZER JJG ABAXIS, INC. 1100-0000 EABA110000001

    Patients

    Seq Age Sex Outcome Treatment
    1