BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ALBP ALBUMIN BCP

    MDR report key: 8551515 · Received April 25, 2019

    Report

    Report Number
    1823260-2019-90096
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJW
    UDI-DI
    04015630927562
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOR BOTH EVENTS: THE INVESTIGATION TESTED RETENTION ALBUMIN REAGENT LOTS WITH PRECICONTROL SOLUTION ON A C 501 MODULE. ALL RESULTS WERE COMPARABLE TO ONE ANOTHER. THE INVESTIGATION ALSO USED 10 BLOOD SAMPLES FROM INTERNAL DONORS. FROM EACH DONOR, A VENOUS SAMPLE AND A CAPILLARY SAMPLE WAS OBTAINED AND TESTED WITH RETENTION ALBUMIN REAGENT ON A C501 MODULE. A DIFFERENCE IN RESULTS BETWEEN VENOUS AND CAPILLARY SAMPLES WAS NOT OBSERVED. THE RESULTS WERE COMPARABLE TO ONE ANOTHER. THE CUSTOMER'S ALLEGATION COULD NOT BE CONFIRMED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    FOR TWO EVENTS THE INVESTIGATIONS ARE ONGOING. THE FOLLOW UP/CORRECTIVE ACTIONS: NONE LISTED. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE>2</NOE> MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY THE COBAS 6000 C (501) MODULE. THE EVENTS INVOLVED A TOTAL OF 2 PATIENTS WITH LOW RESULTS FOR ALBP ALBUMIN BCP. THE PATIENTS' AGES RANGED WERE "NEWBORNS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344250 ALBP ALBUMIN BCP BROMCRESOL PURPLE DYE-BINDING, ALBUMIN CJW ROCHE DIAGNOSTICS ALB BCP 382380, 350769 04015630927562

    Patients

    Seq Age Sex Outcome Treatment
    1