BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE CHOLESTECH LDX MULTIANALYTE CONTROLS

    MDR report key: 5125624 · Received October 2, 2015

    Report

    Report Number
    2027969-2015-00825
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 4, 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
    IA, US
    Reporter Occupation
    DIETICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MDR IS BEING FILED DUE TO FIELD ACTION: REF-2027969-08/25/15-001C. INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    CONTROL LOT C3091A WAS ASSOCIATED WITH FIELD ACTION PER INTERNAL (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. INVESTIGATION WILL BE PERFORMED UNDER INTERNAL (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT CONTROLS WERE OUTSIDE OF THE EXPECTED RANGE - HIGH. RESULTS WERE AS FOLLOWS: TC HIGH TWO TIMES FOR L1. TC=160, 157 (108-152); TRG=132 (129-191). THE RESULTS WERE WITHIN THE CORRECTED EXPECTED VALUES. TECHNICAL SERVICE REVIEWED FACTORS AND INFORMED CUSTOMER OF NOTIFICATION; PROVIDED CORRECTED EXPECTED VALUES RANGES AND EMAILED THE NOTIFICATION TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656651 ALERE CHOLESTECH LDX MULTIANALYTE CONTROLS MULTI-ANALYTE CONTROLS JJY ALERE SAN DIEGO, INC. 88773 C3091A

    Patients

    Seq Age Sex Outcome Treatment
    1