BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTI HIV-1/HIV-2 ANTIBODY TEST

    MDR report key: 6367145 · Received February 28, 2017

    Report

    Report Number
    3003871407-2017-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    December 6, 2016
    Report Date
    February 28, 2017
    Manufacturer
    BIOLYTICAL LABORATORIES INC.
    Product Code
    MZF
    PMA / PMN Number
    BP090032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE (B)(6) RESULTS WERE REPORTED BY A CUSTOMER IN (B)(6) WHEN TESTING THREE DIFFERENT PATIENT SAMPLES WITH (B)(4) ANTIBODY TEST KIT FROM LOT 1512BA033. ALL CUSTOMERS THAT RECEIVED THE INSTI (B)(4) ANTIBODY TEST KIT LOT 1512BA033 WERE INITIALLY ADVISED (BY MEANS OF FIELD SAFETY NOTICE AI002.17.N, DATED 19 JANUARY 2017) TO QUARANTINE ANY KITS FROM THIS LOT REMAINING IN THEIR INVENTORY. BIOLYTICAL LABORATORIES INC. THE MANUFACTURER OF (B)(4) ANTIBODY TEST CONDUCTED A THOROUGH INVESTIGATION USING THE INSTI KITS FROM LOT 1512BA033 THAT WERE RETAINED AT THE MANUFACTURER'S FACILITY AND SAMPLE KITS RETURNED BY THE COMPLAINANT. SERA SAMPLES OF THE PATIENTS THAT TESTED (B)(6) WITH INSTI KITS FROM LOT 1512BA033 WERE ALSO USED BY BIOLYTICAL LABORATORIES INC. TO CONDUCT THE INVESTIGATION. AS PER THE INVESTIGATION RESULTS, ALL PATIENT SAMPLES TESTED (SERA AND SPIKED WHOLE BLOOD) WERE (B)(6) ON ALL INSTI (B)(6) ANTIBODY TEST KITS FROM LOT 1512BA033 (INCLUDING BIOLYTICAL RETAINS AND KITS RETURNED FROM THE CUSTOMER'S SITE). DETAILS OF THE INVESTIGATION ARE PROVIDED BELOW: INITIAL MEDICAL DEVICE REPORT SENT TO (B)(6) ON 13 JAN 2017. FIRST FIELD SAFETY NOTICE TO ADVISE ALL CUSTOMERS TO QUARANTINE THE INSTI (B)(4) TEST KITS FROM LOT 1512BA033 WAS SENT TO ALL CUSTOMERS BY THE IMPORTER ON - 20 JAN 2017. ONE OF THE PATIENTS WAS AN EARLY SERO-CONVERSION AS PROVEN BY THE CONFIRMATORY RESULTS (THE LIMITATION IS STATED IN THE IFU). NO FURTHER INVESTIGATION PERFORMED FOR THIS PATIENT. THREE TUBES OF PATIENT PLASMA SAMPLES FROM THE OTHER TWO PATIENTS WITH (B)(6) RESULTS WERE RECEIVED BY BIOLYTICAL ON 18- JAN-2017. SAMPLE TEST KITS FROM LOT 1512BA033 FROM THE CUSTOMER SITE WAS RECEIVED BY BIOLYTICAL ON 24-JAN-2017. INVESTIGATION COMPLETED BY BIOLYTICAL LABORATORIES INC. ON 31 JAN 2017. FINAL MEDICAL DEVICE REPORT SENT TO (B)(6) ON 02 FEB 2017. PROPOSED FINAL FIELD SAFETY NOTICE TO ADVISE ALL CUSTOMERS TO DISCARD THE REMAINING TEST KITS SENT TO (B)(6) ON 02 FEB 2017. THE FINAL FIELD SAFETY NOTICE WILL BE SENT TO ALL CUSTOMERS BY THE IMPORTER AS SOON AS IT IS APPROVED BY (B)(6) COMPETENT AUTHORITY. CONCLUSION: AS PER THE RESULTS OF INVESTIGATION, ALL PATIENT SAMPLES TESTED AT BIOLYTICAL (SERA AND SPIKED WHOLE BLOOD) WERE (B)(6) ON BOTH INSTI (B)(4) ANTIBODY TEST KIT LOTS TESTED I.E. LOT 1512BA033 AND LOT 1608BB019 (INCLUDING BIOLYTICAL RETAINS AND RETURNED KITS FROM THE CUSTOMER'S SITE). ALTHOUGH THE INTENSITY VARIED BETWEEN LOTS AND SAMPLE TYPES, A CLEAR DOT WAS OBSERVED IN ALL THREE (B)(6) RGA PATIENT SERUM SAMPLES ((B)(6)). BOTH RETAIN KITS AND RETURNED MATERIALS HAD REACTIVE RESULTS AS EXPECTED WITH THE PATIENTS' SAMPLES TESTED WHICH RULES OUT IMPROPER STORAGE FOR THE RETURNED MATERIAL FROM (B)(4) ANTIBODY TEST KIT LOT 1512BA033 BASED ON CONCLUSIONS STATED UNDER 1 TO 3 ABOVE, THE ONLY EXPLANATION FOR THE (B)(6) RESULTS AT THE TESTING CENTER IS OPERATOR ERROR (ERRONEOUS RESULTS READING/ INCORRECT RESULT INTERPRETATION OR PERFORMING THE TEST INCORRECTLY). ALTHOUGH THE INSTI (B)(4) ANTIBODY TEST KIT (LOT 1512BA033) IN QUESTION IS PERFORMING AS EXPECTED AND THE (B)(6) WERE NOT REPLICATED FOLLOWING OUR INVESTIGATION, WE WILL RECOMMEND TO ALL SITES THAT RECEIVED INSTI (B)(4) ANTIBODY TEST KIT (LOT 1512BA033) TO DISCARD ANY REMAINING INVENTORY OF THIS LOT. PLEASE FIND ENCLOSED THE PROPOSED FIELD SAFETY NOTICE IN FRENCH LANGUAGE THAT HAS BEEN SENT TO (B)(6) FOR APPROVAL AND AN ENGLISH TRANSLATION. THE (B)(4) ANTIBODY TEST KIT LOT 1512BA033 WAS DISTRIBUTED BY (B)(4) ONLY TO LABORATORIES (B)(6).

    Description of Event or Problem · 1

    THIS IS A FOREIGN INCIDENT BEING REPORTED TO FDA AS PART OF THE MANDATORY REPORTING OF FOREIGN INCIDENTS. THE TEST KITS INVOLVED IN THIS INCIDENT WERE NOT DISTRIBUTED IN THE U.S. THREE (B)(6) RESULTS WERE REPORTED BY A CUSTOMER IN (B)(6) WHEN TESTING THREE DIFFERENT PATIENT SAMPLES WITH (B)(4) ANTIBODY TEST KIT FROM LOT 1512BA033. ALL CUSTOMERS THAT RECEIVED THE (B)(4) ANTIBODY TEST KIT LOT 1512BA033 WERE INITIALLY ADVISED (BY MEANS OF FIELD SAFETY NOTICE AI002.17.N, DATED 19 JANUARY 2017) TO QUARANTINE ANY KITS FROM THIS LOT REMAINING IN THEIR INVENTORY. BIOLYTICAL LABORATORIES INC. THE MANUFACTURER OF (B)(4) ANTIBODY TEST CONDUCTED A THOROUGH INVESTIGATION USING THE INSTI KITS FROM LOT 1512BA033 THAT WERE RETAINED AT THE MANUFACTURER'S FACILITY AND SAMPLE KITS RETURNED BY THE COMPLAINANT. SERA SAMPLES OF THE PATIENTS THAT TESTED (B)(6) WITH INSTI KITS FROM LOT 1512BA033 WERE ALSO USED BY BIOLYTICAL LABORATORIES INC. TO CONDUCT THE INVESTIGATION. ONE OF THE PATIENTS WAS AN EARLY SERO-CONVERSION AS PROVEN BY THE CONFIRMATORY RESULTS (THE LIMITATION IS STATED IN THE IFU). NO FURTHER INVESTIGATION PERFORMED FOR THIS PATIENT. THREE TUBES OF PATIENT PLASMA SAMPLES FROM THE OTHER TWO PATIENTS WITH (B)(6) RESULTS WERE RECEIVED BY BIOLYTICAL ON 18- JAN-2017. SAMPLE TEST KITS FROM LOT 1512BA033 FROM THE CUSTOMER SITE WAS RECEIVED BY BIOLYTICAL ON 24-JAN-2017. AS PER THE INVESTIGATION RESULTS, ALL PATIENT SAMPLES TESTED (SERA AND SPIKED WHOLE BLOOD) WERE (B)(6) ON ALL (B)(4) ANTIBODY TEST KITS FROM LOT 1512BA033 (INCLUDING BIOLYTICAL RETAINS AND KITS RETURNED FROM THE CUSTOMER'S SITE). ALTHOUGH THE DOT INTENSITY VARIED BETWEEN TEST KITS AND SAMPLE TYPES, A CLEAR DOT WAS OBSERVED IN ALL PATIENT SAMPLES. BOTH RETAIN AND RETURNED KITS FROM LOT 1512BA033 SHOWED (B)(6) RESULTS AND PERFORMED EQUIVALENT WITH THE PATIENT SAMPLES TESTED. BASED ON THE INVESTIGATION RESULTS, IT IS EVIDENT THAT THE (B)(4) ANTIBODY TEST KITS FROM LOT 1512BA033 PERFORM AS EXPECTED. (B)(6) WERE NOT OBSERVED DURING THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146213 INSTI HIV-1/HIV-2 ANTIBODY TEST HIV RAPID TESTS MZF BIOLYTICAL LABORATORIES INC. 90-1016 1512BA033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other