BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 10237530 · Received July 6, 2020

    Report

    Report Number
    2939693-2020-00064
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    November 15, 2018
    Report Date
    June 25, 2021
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    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 EMITTING A BURNING PLASTIC SMELL WHILE THE DEVICE WAS ON. NO FIRE OR INJURY WAS REPORTED. THE CUSTOMER STATED THAT THEY CLEANED THE FILTERS WEEKLY AND MONTHLY. THE CUSTOMER SENT THE DEVICE IN FOR REPAIR. DURING EVALUATION OF THE DEVICE, THE CUSTOMER PROBLEM COULD NOT BE DUPLICATED. THE DEVICE'S ELECTRONIC AND MECHANICAL ASSEMBLIES WERE CHECKED AND TESTED, AND MET FACTORY SPECIFICATION. NUMEROUS TESTINGS WERE PERFORMED ON THE ANALYZER ASSEMBLY AND NO PROBLEMS WERE FOUND. THE FAN FILTER WAS REPLACED AS A PRECAUTION. THE DEVICE UNDERWENT ABAXIS REPAIR SYSTEM TESTING, WAS CLEANED, AND 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 (B)(6) 2019. THERE HAS BEEN NO REOCCURRENCE REGARDING THE ISSUE OF BURNING SMELL WITH THIS DEVICE POST REPAIRS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS EMITTING A BURNING PLASTIC SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701882 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO ANALYZER JJG ABAXIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1