BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7554550 · Received May 30, 2018

    Report

    Report Number
    1221359-2018-00073
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Report Date
    May 30, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE TESTING WAS PERFORMED ON RETAINED KIT LOT 160911 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: (B)(6), (B)(6), P24 (B)(6), AND (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 160911 WAS REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CUSTOMER REPORTED APPROXIMATELY 10 (B)(6) RESULTS. IT IS UNKNOWN IF THESE WERE 10 INDIVIDUAL PATIENTS OR IF ANY OF THESE TESTS WERE REPEATS ON THE SAME PATIENT. AN ON-SITE INVESTIGATION REVEALED THAT THE CUSTOMER WAS NOT FOLLOWING LABEL INSTRUCTIONS FOR PERFORMING THE ALERE DETERMINE HIV1/2 AG/AB COMBO TEST. THERE WERE ISSUES IDENTIFIED IN THE SAMPLE COLLECTION AND APPLICATION TO THE TEST STRIP AND ISSUES WITH THE ADDITION OF THE CHASE BUFFER. A REVIEW OF THE COMPLAINTS REPORTED (B)(6) OR UNCONFIRMED (B)(6) RELATED TO LOT NUMBER 160911 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE RESULTS OBTAINED MAY POSSIBLY BE RELATED TO THE PATIENT SAMPLE. THE SAMPLE MAY HAVE CONTAINED SPECIFIC SUBSTANCES WHICH MAY HAVE AFFECTED THE RESULTS. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 10 (B)(6) RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. IT IS UNKNOWN IF THESE WERE 10 INDIVIDUAL PATIENTS OR IF ANY OF THESE TESTS WERE REPEATS ON THE SAME PATIENT. DATE OF EVENT NOT REPORTED. CONFIRMATORY TESTING PERFORMED AT QUEST USING A 4TH GENERATION (B)(6) TEST, UNKNOWN METHOD, WAS NEGATIVE. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4); HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396032 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 160911

    Patients

    Seq Age Sex Outcome Treatment
    1