BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE HCG CASSETTE

    MDR report key: 17000932 · Received May 25, 2023

    Report

    Report Number
    3005641941-2023-00003
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    January 9, 2023
    Report Date
    May 25, 2023
    Manufacturer
    ABON BIOPHARM (HANGZHOU) CO., LTD.
    Product Code
    JHI
    UDI-DI
    16952999401300
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING FILED FOR THIS PRODUCT, FHC-102 ALERE HCG DEVICE (URINE) 20T, LOT 0000606047, AS THIS PRODUCT IS SAME/SIMILAR TO PRODUCT WHICH IS MARKETED IN THE US UNDER 510(K) K993317. PLEASE SEE BELOW FOR A SUMMARY OF INVESTIGATION CONDUCTED AND CONCLUSION: RETAIN PRODUCT TESTING WAS PERFORMED ON LOT 0000606047; 10 RETAINED DEVICES FROM THIS LOT WERE VISUALLY INSPECTED INCLUDING PACKAGING AND ALL WERE FOUND TO BE INTACT AND NO NON-CONFORMANCES NOTED. FIVE RETAINED DEVICES WERE TESTED WITH 25MIU/ML HCG URINE AND 5 RETAINED DEVICES WERE TESTED WITH HIGH HCG CLINICAL URINE SAMPLES AND RESULTS WERE READ AT 3 MINUTES AS PER THE IFU (INSTRUCTION FOR USE). THE TESTING RESULTS INDICATED THAT ALL DEVICES YIELDED CORRECT POSITIVE RESULTS ON THE QC CUT-OFF STANDARD AND HIGH HCG CLINICAL URINE SAMPLE. FALSE NEGATIVE RESULTS WERE NOT OBSERVED. THE ALLEGED FALSE NEGATIVE RESULT WAS NOT REPLICATED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING BATCH RECORDS FOR LOT 0000606047 WERE REVIEWED AND CONFIRMED THAT THERE WERE NO NON-CONFORMANCES OR MANUFACTURING DEVIATIONS FOR THIS LOT AND THE QUALITY CONTROL (QC) RELEASE DATA MET QC SPECIFICATION. THE FHC-102 RISK MANAGEMENT REPORT (B)(4) WAS REVIEWED AND FALSE NEGATIVE RESULTS HAS BEEN ASSESSED; NO NEW HAZARD IDENTIFIED. THE COMPLAINT HISTORY DATA FOR THIS PRODUCT FOR FALSE NEGATIVES WITHIN THE LAST TWO YEAR TIME PERIOD (07-MAY -2021 TO 05-JUNE-2023) WAS REVIEWED. 7 FALSE NEGATIVE COMPLAINTS HAVE BEEN RECEIVED TO DATE. THIS IS THE ONLY COMPLAINT RECEIVED REPORTING A FALSE NEGATIVE RESULT FOR LOT 0000606047. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED AND TRACKED. INFORMATION REGARDING PRODUCT STORAGE AND TESTING TECHNIQUE WAS NOT PROVIDED AND THEREFORE, ANY MISUSE OR DEVIATION AGAINST THE IFU COULD NOT BE DETERMINED. INVESTIGATION CONCLUSION: FROM REVIEW OF THE COMPLAINT, INSUFFICIENT EVIDENCE WAS PROVIDED TO DETERMINE THE MOST PROBABLE CAUSE. IT CAN BE CONFIRMED THAT NO DEATH, SERIOUS INJURY OR PRODUCT DEFICIENCY WAS IDENTIFIED DURING THIS INVESTIGATION.

    Description of Event or Problem · 0

    ON THE 03 MAY 2023 ABBOTT WAS NOTIFIED BY THE UK¿S MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) OF AN ADVERSE INCIDENT LOGGED, UNDER MHRA REFERENCE NUMBER: (B)(4). THE DATE OF THE REPORTED INCIDENT WAS THE (B)(6) 2023 AND THE PRODUCT ASSOCIATED WITH THE COMPLAINT IS FHC-102 ALERE HCG DEVICE (URINE) 20T, LOT 0000606047, EXPIRY DATE 08 AUGUST 2024. IT WAS REPORTED THAT A FALSE NEGATIVE RESULT WAS OBTAINED, FOLLOWING A POSITIVE RESULT EARLIER THAT SAME DAY. A CONFIRMATORY BLOOD HCG SAMPLE TEST WAS COMPLETED LATER THAT DAY WHICH SHOWED A POSITIVE RESULT. THE PRODUCT FHC-102 ALERE HCG DEVICE(URINE) 20T HAS BEEN IDENTIFIED AS SAME/ SIMILAR TO PRODUCT FHC-102B THAT IS MARKETING IN THE US. THE REPORTABILITY ASSESSMENT CONDUCTED BY ABBOTT CONCLUDED THAT THIS INCIDENT MEETS THE FDA ADVERSE EVENT MEDICAL DEVICE REPORTING (MDR) CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808153 ALERE HCG CASSETTE (HCG) PREGNANCY TEST DEVICE (URINE) JHI ABON BIOPHARM (HANGZHOU) CO., LTD. FHC-102 0000606047 16952999401300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown