BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 6963135 · Received October 19, 2017

    Report

    Report Number
    1221359-2017-00004
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    July 13, 2017
    Report Date
    July 18, 2017
    Manufacturer
    ALERE SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    07290015003735
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT TWO LOTS OF ALERE DEVICES WERE USED. THE ADDITIONAL LOT IS AS FOLLOWS: CATALOG #: 7D2648. LOT # = 089322. EXPIRATION DATE = 06/SEP/2018. MANUFACTURED DATE = 31/MAY/2017. (B)(4). THE CUSTOMER PROVIDED RESIDUAL SAMPLE TO ALERE FOR TESTING WITH A RETAINED KIT OF LOT 161227 AND OF LOT 089322. ALL RESULTS WERE VALID AND THE DEVICE PERFORMED AS EXPECTED. THE PATIENT SAMPLE GAVE POSITIVE ANTIGEN AND ANTIBODY CAPTURE LINES. CUSTOMER COMPLAINT WAS NOT REPLICATED. THE CUSTOMER PROVIDED A PHOTOGRAPH OF 3 USED DEVICES. THE FIRST DEVICE APPEARED TO HAVE BEEN TESTED WITH PLASMA. IT APPEARED TO BE VALID, AB POSITIVE, AND AG NEGATIVE. THE SECOND AND THIRD DEVICES APPEARED TO HAVE BEEN TESTED WITH WHOLE BLOOD, BUT UNKNOWN WHICH LOT EITHER OF THEM REPRESENT. BOTH APPEARED TO BE VALID, AB NEGATIVE, AND AG NEGATIVE. NO DEVICE DEFECTS WERE NOTED. IN CONCLUSION, THE INTERNAL TESTING OF THE DEVICE LOTS FROM RETAINED KITS YIELDED EXPECTED RESULTS WHEN TESTING WITH INTERNAL QC SAMPLES. THE MANUFACTURING BATCH RECORD REVIEW FOR BOTH LOTS OF DEVICES DID NOT REVEAL ANY FAILURES OF ACCEPTANCE CRITERIA. ALERE SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE RESULTS OBTAINED MAY POSSIBLY BE RELATED TO THE PATIENT SAMPLE. THE SAMPLE MAY HAVE CONTAINED SPECIFIC SUBSTANCES WHICH MAY HAVE AFFECTED THE RESULTS. A REVIEW OF THE COMPLAINTS REPORTED FOR THIS PHENOMENON RELATED TO LOT NUMBER 161227 SHOWED THAT THE COMPLAINT RATE IS 0.014 %. A REVIEW OF THE COMPLAINTS REPORTED FOR THIS PHENOMENON RELATED TO LOT NUMBER 089322 SHOWED THAT THE COMPLAINT RATE IS 0.003%. EVIDENCE AVAILABLE DOES NOT INDICATE THAT THIS DEVICE LOT IS PERFORMING OUTSIDE OF LABEL CLAIMS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MULTIPLE FALSE NEGATIVE RESULTS WITH ALERE DETERMINE HIV-1/2 AG/AB COMBO ON TWO DIFFERENT DAYS USING FINGERSTICK WHOLE BLOOD AND PLASMA SAMPLES FROM A SINGLE, SYMPTOMATIC PATIENT WITH PRIOR POSITIVE HIV TESTING USING OTHER TESTS. TEST 1) FINGERSTICK SAMPLE WITH LOT 161227 ON (B)(6)2017, RESULT = NEGATIVE. TEST 2) FINGERSTICK SAMPLE WITH LOT 161227 ON (B)(6)2017, RESULT = NEGATIVE. TEST 3) FINGERSTICK SAMPLE WITH LOT 089322 ON (B)(6)2017, RESULT = NEGATIVE. TEST 4) PLASMA SAMPLE WITH LOT 161227 ON (B)(6) 2017, RESULT = NEGATIVE. SUBSEQUENT CONFIRMATORY TESTING WITH VIRAL LOAD DEMONSTRATED POSITIVE RESULTS. ANTIRETROVIRAL THERAPY WAS NOT REPORTED AT THE TIME OF TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740807 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH, INC. 161227 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR