BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7603324 · Received June 14, 2018

    Report

    Report Number
    1221359-2018-00318
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Report Date
    June 14, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    UDI-DI
    10811877010323
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED KIT LOT 090156 WITH THE FOLLOWING INTERNAL SERUM/PLASMA CONTROL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 090156 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE IN THE CASE, IT APPEARS A MALFUNCTION MAY HAVE OCCURRED WITH ONE OF THE TWO CONFLICTING ALERE DETERMINE HIV TESTS. THE INTERNAL RETENTION TESTING DID NOT REPLICATE THE ISSUE WHICH INDICATED THE DEVICE LOT WAS PERFORMING AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE OR UNCONFIRMED FALSE POSITIVE RELATED TO LOT NUMBER 090156 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ALERE (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TWO (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO RESULTS ON TWO DIFFERENT PATIENTS SEEN IN THE EMERGENCY ROOM ON THE SAME NIGHT. DATE OF EVENT NOT REPORTED. THIS REPORT REPRESENTS ONE OF THE TWO OCCURRENCES. A (B)(6) RESULT WAS REPORTED ON A FINGERSTICK WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE TEST WAS REPEATED (FINGERSTICK WHOLE BLOOD) WITH A DIFFERENT LOT (UNKNOWN LOT NUMBER) OF ALERE DETERMINE HIV 1/2 AG/AB COMBO AND OBTAINED A (B)(6) RESULT. IT IS UNKNOWN IF OTHER CONFIRMATION TESTS WERE PERFORMED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. BASED ON THE INFORMATION AVAILABLE IN THE CASE, IT APPEARS A MALFUNCTION MAY HAVE OCCURRED WITH ONE OF THE TWO CONFLICTING ALERE DETERMINE HIV 1/2 AG/AB TESTS. THE INTERNAL RETENTION TESTING DID NOT REPLICATE THE ISSUE WHICH INDICATED THE DEVICE LOT WAS PERFORMING AS EXPECTED. THIS WILL BE FILED AS 2 SEPARATE MDR REPORTS. 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
    446307 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 090156 10811877010323

    Patients

    Seq Age Sex Outcome Treatment
    1