BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7598511 · Received June 13, 2018

    Report

    Report Number
    1221359-2018-00118
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Report Date
    May 11, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALERE WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE KIT'S LOT NUMBER WAS NOT PROVIDED FOR A SPECIFIC INVESTIGATION. THE SAMPLE WAS NOT RETURNED FOR FURTHER TESTING, AND NO ADDITIONAL INFORMATION SUCH AS MEDICAL HISTORY WAS PROVIDED. A REVIEW OF COMPLAINT TRENDS REVEAL THAT ALL DETERMINE COMBO LOTS ARE PERFORMING ACCORDING TO LABEL CLAIMS.

    Description of Event or Problem · 1

    SIXTEEN (B)(6) RESULTS (THE EXACT NUMBER OF PATIENTS VERSUS TESTS PERFORMED IS UNKNOWN) WERE REPORTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO IN A STUDY, OUT OF A TOTAL OF 2918 TESTS ((B)(6)). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. LOT NUMBERS WERE NOT PROVIDED AND PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE DATE OF THE EVENTS ARE NOT KNOWN. THIS INFORMATION WAS PROVIDED AS A CASE STUDY SUMMARY REPORT AND SPECIFIC DETAILS ABOUT INDIVIDUAL EVENTS WERE NOT AVAILABLE. THIS CASE WAS EVALUATED PER THE (B)(6) 2016, MEDICAL DEVICE REPORTING FOR MANUFACTURERS, GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF AND THIS SUMMARY CASE WILL BE REPORTED AS IT COULD NOT BE CONFIRMED THAT ALL INDIVIDUAL EVENTS HAD BEEN EVALUATED FOR REPORTABILITY REQUIREMENTS. 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), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED (B)(6) TO (B)(6) 2018 AT ALERE (B)(4), INC. ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439002 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1