BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPREHENSIVE METABOLIC PANEL REAGENT DISC

    MDR report key: 10792303 · Received November 4, 2020

    Report

    Report Number
    MW5097661
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    November 2, 2020
    Report Date
    November 2, 2020
    Manufacturer
    ABAXIS, INC.
    Product Code
    JLB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PRODUCT: PICCOLO COMPREHENSIVE METABOLIC PANEL REAGENT DISC, ABAXIS, INC., PUBLISHED ASSAY INTERFERENCES BY MANUFACTURER ARE INCONSISTENT. IN TABLE 2 OF THE CURRENT PACKAGE INSERT, IT IS CLAIMED THAT THE HIGHEST CONCENTRATION TESTED OF ASCORBIC ACID IS 3 MG/DL. IN TABLE 3, THE STATED LEVEL OF ASCORBIC ACID THAT CAUSES SIGNIFICANT INTERFERENCE IS 20 MG/DL (PRESUMABLY, UNITS ARE NOT INCLUDED IN THE TABLE HEADER), AFFECTING THE ASSAYS FOR ALT, CREATININE, CARBON DIOXIDE. WHILE THE CLINICAL RELEVANCE OF THESE CONCENTRATIONS MAY BE LIMITED, THESE TWO TABLES PROVIDE CONFLICTING INFORMATION REGARDING THE POTENTIAL FOR INTERFERENCE ON THESE THREE ASSAYS. THIS HAS BEEN REPORTED TO THE MANUFACTURER BY MORE THAN ONE GROUP TO OUR KNOWLEDGE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247848 PICCOLO COMPREHENSIVE METABOLIC PANEL REAGENT DISC ATP AND CREATINE KINASE (ENZYMATIC), CREATINE JLB ABAXIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1