BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS

    MDR report key: 5241156 · Received November 20, 2015

    Report

    Report Number
    2027969-2015-00948
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    September 18, 2015
    Report Date
    September 18, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JJY
    PMA / PMN Number
    K102700
    Removal / Correction Number
    2027969-08/25/15-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL LOT (C3091A) WAS ASSOCIATED WITH FIELD ACTION PER (B)(4) FOR INCORRECT EXPECTED VALUE CARD PROVIDED WITH THIS CONTROL LOT WITH THE INCORRECT CONCENTRATION ASSIGNMENT RANGES FOR THE TOTAL CHOLESTEROL AND TRIGLYCERIDES ANALYTES. NO FURTHER INVESTIGATION WILL BE PURSUED UNDER THIS CASE.

    Description of Event or Problem · 1

    REPORT RECEIVED OF UNEXPECTED HIGH CONTROL VALUES RECEIVED OUTSIDE OF RANGE FOR LDX MULTI-ANALYTE CONTROLS (L1 & L2). CONTROLS L1 HIGH: TC=257 (133-187), HDL=67 (21-41), TRG=212 (105-155), LDL=148 (96-142). NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769678 ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS MULTI-ANALYTE CONTROLS JJY ALERE SAN DIEGO, INC. 88773 C3091A

    Patients

    Seq Age Sex Outcome Treatment
    1