BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO BASIC METABOLIC PANEL

    MDR report key: 10721960 · Received October 22, 2020

    Report

    Report Number
    2939693-2020-00100
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    September 22, 2020
    Report Date
    February 11, 2021
    Manufacturer
    ABAXIS, INC.
    Product Code
    CGX
    PMA / PMN Number
    K992140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED WITH INVESTIGATION FINDINGS. THE INVESTIGATION WAS PERFORMED ON ALL PICCOLO XPRESS PACKAGE INSERTS TO EVALUATE THE EXTENT OF THE ISSUE. THE INVESTIGATION CONFIRMED THE CUSTOMER COMPLAINT OF DISCREPANCIES BETWEEN TABLE 2 AND TABLE 3 OF THE PACKAGE INSERTS OF THE COMPREHENSIVE METABOLIC PANEL AND THE BASIC METABOLIC PANEL. THIS ERROR WAS ALSO ENCOUNTERED IN FURTHER PACKAGE INSERTS FOR WHICH ABAXIS/ZOETIS NEVER RECEIVED ANY CUSTOMER COMPLAINT. TO CLASSIFY THE RISK FOR PATIENT HARM, ZOETIS REACHED OUT TO A MEDICAL PROFESSIONAL FOR ASSISTANCE AND GUIDANCE. A HEALTH HAZARD EVALUATION WAS COMPLETED AND SIGNED BY A MEDICAL PROFESSIONAL. IT WAS DEEMED THAT THE RISK FOR A SERIOUS INJURY OR DETERIORATION IN PATIENT HEALTH RELATED TO ABOVE ERROR IS CONSIDERED AS LOW TO VERY LOW. THE FOLLOWING LIST SHOWS THE PANELS WITH EFFECTED PARAMETERS AS WELL AS THE ASSOCIATED 510K FILE NUMBERS RELATED TO THOSE PARAMETERS. ELECTROLYTE PANEL - K992140 METLYTE 8 PANEL - K950164, K992140 BASIC METABOLIC PANEL - K950164, K992140 RENAL FUNCTION PANEL - K950164, K992140 COMPREHENSIVE METABOLIC PANEL - K950164, K992140 METLYTE PLUS CRP - K950164, K992140 METLAC 12 PANEL - K950164, K992140 AMLYTE 13 - K950164, K992140 THE PACKAGE INSERTS FOR ELECTROLYTE PANEL (2001), METLYTE 8 PANEL (2001), BASIC METABOLIC PANEL (2001), RENAL FUNCTION PANEL (2002) COMPREHENSIVE METABOLIC PANEL (2003), METLYTE PLUS CRP (2009), METLAC 12 PANEL (2012) AND AMLYTE 13 (2014) WERE INVESTIGATED AT "REVISION A". ALL OF THEM ALREADY SHOWED THE ISSUE, BUT RENAL FUNCTION PANEL HAS A DIFFERENT DESIGN IN "REVISION A." THE REVIEW OF THE PACKAGE INSERTS SHOWED THAT THREE DIFFERENT DESIGNS ARE CURRENTLY IN USE. ACTION ITEMS TO CORRECT THE ISSUE INCLUDE ALIGNING THE 17 PACKAGE INSERTS FOR SECTION 9 SUB-SECTION EFFECTS OF THERAPEUTIC SUBSTANCES. A MEDICAL PROFESSIONAL OUTLINED IN HIS REVIEW THAT THE CURRENT PRESENTATION IS NOT EASY TO UNDERSTAND FOR NON-LABORATORY PROFESSIONALS. CAPA 20-022-A HAS BEEN OPENED TO ADDRESS THE ISSUE AND PI LABEL CORRECTION. ZOETIS WILL WORK WITH SPECIALISTS TO PRESENT THE DATA IN RELATION TO THERAPEUTIC RELEVANT RANGES AND OUTLINE IF PROVIDED RANGES ARE THERAPEUTIC OR PHYSIOLOGIC.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, ABAXIS RECEIVED A CALL WHERE A CUSTOMER REPORTED A DISCREPANCY IN THE PACKAGING INSERT FOR THE BMP PANEL (DOCUMENT (B)(4)) STATING THAT, UNDER THE SECTION, "EFFECTS OF EXOGENOUS AND THERAPEUTIC SUBSTANCES," TABLE 2 INDICATES THAT THE CONCENTRATIONS LISTED ARE THE HIGHEST CONCENTRATIONS TESTED; HOWEVER, IN TABLE 3, THE VALUES LISTED FOR ASCORBIC ACID AND DOPAMINE ARE HIGHER THAN THE VALUES INDICATED IN TABLE 2 AND PYRUVATE IS NOT LISTED IN TABLE 2, BUT IS INCLUDED IN TABLE 3. AN ADDITIONAL 510(K) RELEVANT FOR THIS ISSUE IS K950164. ABAXIS IS CURRENTLY CONDUCTING A ROOT CAUSE INVESTIGATION INTO THE POTENTIAL DISCREPANCY CONCERNS AND WILL PROVIDE A FOLLOW-UP REPORT FOLLOWING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISCREPANCY IN THE INFORMATION INDICATED IN THE PACKAGING INSERT FOR THE BASIC METABOLIC PANEL (DOCUMENT (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187932 PICCOLO BASIC METABOLIC PANEL BASIC METABOLIC PANEL CGX ABAXIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1