BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® HCG 60 TESTS

    MDR report key: 14644522 · Received June 9, 2022

    Report

    Report Number
    8020790-2022-00067
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Report Date
    July 24, 2022
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JHI
    UDI-DI
    03573026156923
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE UNITED STATES THAT THEY OBTAINED OVERESTIMATED RESULT WHEN TESTING EXTERNAL QUALITY CONTROL ON VIDAS HCG 60 TESTS (REF. 30405-01, BATCH NUMBER: 1009059670, EXPIRY DATE: 29-OCT-2022). THE QUALITY CONTROL SAMPLE (LEVEL 3, LOT: 40413) GAVE AN INITIAL RESULT OF 488.08 IU/ML FOR AN EXPECTED RANGE OF [222-388] AND THEN THE QUALITY CONTROL SAMPLE GAVE A RESULT OF 283.97 IU/ML WHEN TESTED AGAIN. UNFORTUNATELY, IT WAS NOT POSSIBLE TO GET MORE INFORMATION ABOUT THE CONDITIONS OF INITIAL RUN AND RERUN ( INCLUDING THE SIGNALS MEASURED, POSITIONS ON THE INSTRUMENT, CALIBRATION DATA, IF SAME VIAL OF QC SAMPLE USED). INVESTIGATION: NO MATERIAL RECEIVED FROM THE CUSTOMER. COMPLAINT ANALYSIS: AS OF THE DATE OF THIS INVESTIGATION, WE HAVE RECORDED ONLY THIS CUSTOMER¿S COMPLAINT FOR PERFORMANCE ISSUE ON VIDAS HCG LOT: 1009059670. CONTROL CHART ANALYSIS: ANALYSIS WAS CARRIED OUT ON FOUR (4) INTERNAL SAMPLES WITH RESPECTIVE TARGETS BETWEEN 2.00 AND 231 MIU/ML, USING SEVEN (7) BATCHES OF VIDAS HCG INCLUDING THE CUSTOMER¿S LOT: (1009059670). ALL RESULTS ARE WITHIN SPECIFICATIONS AND THE LOT MENTIONED BY THE CUSTOMER IS CONSISTENT COMPARED TO THE OTHER LOTS. INTERNAL SAMPLE TESTING: THE COMPLAINTS LABORATORY TESTED 4 INTERNAL SAMPLES ( TARGETS < 2.68 / 1.08 / 5.11 / 36.3 AND 156 MIU/ML) ON THE RETAIN KIT OF VIDAS HCG LOT: 1009059670 (LOT MENTIONED BY THE CUSTOMER). THE RESULTS COMPLIED WITH THE SPECIFICATIONS WITHOUT ANY SIGNIFICANT DIFFERENCE COMPARED TO THOSE OBSERVED BEFORE THE BATCH RELEASE. BIOMÉRIEUX DID NOT OBSERVE ANY EVOLUTION OVER TIME OF THESE SAMPLES ACTIVITY. QUALITY CONTROL TESTING: THE COMPLAINTS LABORATORY TESTED A SPECIMEN OF THE QUALITY CONTROL SAMPLE LYPHOCHECK IMMUNOASSAY CONTROL PLUS LEVEL 3, LOT: 40413 (ALREADY IN STOCK IN OUR LABORATORY) ON THE RETAIN KIT OF VIDAS HCG LOT: 1009059670. THE QUALITY CONTROL SAMPLE TESTED IN DUPLICATE GAVE A RESULT OF 302.54 AND 283.59 MIU/ML SO WITHIN THE ACCEPTABLE RANGE ESTABLISHED BY BIORAD {222-388} AND NOT SO FAR FROM THE TARGET OF 305 MIU/ML. CONCLUSION: THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE ISSUE REPORTED BY THE CUSTOMER (RESULT TOO HIGH) WHEN TESTING INTERNAL SAMPLES AND THE SAMPLE ¿LYPHOCHECK IMMUNOASSAY PLUS CONTROL¿ LEVEL 3, LOT: 40413 ON VIDAS HCG LOT: 1009059670. WITHOUT THE CUSTOMER¿S MATERIAL AVAILABLE AND RELEVANT INFORMATION CONCERNING THE OPERATING CONDITIONS, IT WAS NOT POSSIBLE TO PURSUE FURTHER THE INVESTIGATION AND WE DID NOT MANAGE TO IDENTIFY ANY OBVIOUS ROOT CAUSE. ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF VIDAS HCG REF.30405-01, LOT: 1009059670.

    Description of Event or Problem · 0

    A CUSTOMER FROM UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING OVERESTIMATED RESULT WHEN TESTING EXTERNAL QUALITY CONTROL ON VIDAS HCG 60 TESTS (REF. 30405-01, BATCH NUMBER: 1009059670, EXPIRY DATE: 29-OCT 2022). THE CUSTOMER REPORTED THAT THE EXTERNAL CONTROLS LEVEL 3 RESULT WAS TOO HIGH WHEN ANALYZED WITH VIDAS HCG 60 TESTS (REF. 30405-01, BATCH NUMBER: 1009059670). THE CUSTOMER DID NOT PROVIDE THE RESULT OBTAINED AND EXPECTED WITH THE EXTERNAL CONTROLS LEVEL 3. THE CUSTOMER ALSO MENTIONED THAT THE CONTROLS PROVIDED IN THE VIDAS KIT WERE CONFORM. THE CUSTOMER ALSO COMPARED THESE EXTERNAL RESULTS WITH ANOTHER INSTRUMENT THAT'S NOT A MINIVIDAS. FOLLOWING THIS ISSUE, THE CUSTOMER REQUESTED AN FSE (FIELD SERVICE ENGINEER) TO BE DISPATCHED ON SITE. AS IT WAS AN EXTERNAL QUALITY CONTROL, NO PATIENT SAMPLE WAS INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726025 VIDAS® HCG 60 TESTS VIDAS® HCG 60 TESTS JHI BIOMERIEUX SA 30405-01 1009059670 03573026156923

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown