BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD SAMPLE COLLECTION KIT

    MDR report key: 14958279 · Received July 8, 2022

    Report

    Report Number
    3015209536-2022-00006
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    March 3, 2022
    Report Date
    July 8, 2022
    Manufacturer
    PRIVAPATH DIAGNOSTICS LTD
    Product Code
    PQD
    UDI-DI
    00850024881341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LETSGETCHECKED (LGC) HAS RECEIVED 16 COMPLAINTS ASSOCIATED WITH THE BLOOD SAMPLE COLLECTION KIT LOT NUMBER: 20391 WHERE ONE USER RECEIVED A SAMPLE COLLECTION KIT THAT WAS LINKED TO ANOTHER USER IN OUR SYSTEM. LGC PROVIDES THESE KITS TO THE LAY USERS THROUGH A PARTNERSHIP WITH A CLIENT. THE USERS COLLECT THE BLOOD SAMPLE UTILIZING THE LGC BLOOD SAMPLE COLLECTION KIT AND RETURN THE SAMPLE FOR HEPATITIS C TESTING BY OUR PARTNER LABORATORY. THE TEST RESULTS ARE SHARED WITH THE USER BY LETTER. THE USER ALSO RECEIVES A CALL FROM THE LGC'S NURSING TEAM TO DISCUSS THE RESULTS OBTAINED. IN ADDITION, THE RESULTS ARE ALSO SHARED WITH THE LGC CLIENT. EACH USER REGISTRATION IS LINKED TO A UNIQUE BAR CODE THROUGH A REGISTRATION PROCESS WITHIN OUR SYSTEM WHICH ENABLES THE IDENTIFICATION OF THE USER DETAILS AND DEMOGRAPHICS WITH THE SAMPLE RETURNED FOR TESTING BY OUR PARTNER LABORATORY. THE COMPLAINT ASSOCIATED WITH THE BAR CODE: LGC-3550-6396-7435 WAS LOGGED IN OUR SYSTEM WITH COMPLAINT NUMBER: (B)(4) ON (B)(6) 2022. A HEALTH HAZARD EVALUATION WAS COMPLETED ON (B)(6) 2022 THROUGH WHICH THE HAZARD RISK INDEX WAS DEEMED TO BE LOW. THE REPORTABILITY ASSESSMENT OF THIS COMPLAINT (B)(4) WAS COMPLETED ON (B)(6) 2022 AND THE COMPLAINT WAS DEEMED AS NOT REPORTABLE DUE TO THE FOLLOWING MITIGATION PROCESSES: 1) THE SAMPLE IS USUALLY COLLECTED BY THE CLIENT'S HEALTHCARE PROFESSIONAL (NURSE) AT THE USER'S HOUSE. IT IS EXPECTED THAT THE NURSE WILL MATCH THE DEMOGRAPHICS ON THE KIT (USER NAME) WITH THE USER'S DETAILS AND NOTICE THE MISMATCH ISSUE. ALTERNATIVELY, THE USER CAN SELF-COLLECT THE SAMPLE AND COULD ALSO IDENTIFY THAT THE DETAILS ON THE LABEL TO NOT MATCH WITH THEIRS. 2) WHEN THE CLIENT'S NURSE OR THE USER CALLS LGC TO ORGANIZE THE COLLECTION OF THE SAMPLE BY THE COURIER, THE LGC CUSTOMER SERVICES AGENT SHOULD BE NOTICE THAT THE DEMOGRAPHICS PROVIDED BY THE CLIENT'S NURSE OR USER DO NOT MATCH WITH THE REGISTRATION LINKED TO THE BAR CODE. 3) THE CLIENT'S NURSE AND/OR THE USER COMPLETE A LABEL ON THE KIT WITH THEIR DEMOGRAPHICS WHICH ARE USED BY THE LGC PARTNER LABORATORY TO MATCH WITH THE USER'S DETAILS IN OUR SYSTEM. SAMPLES THAT HAVE MISMATCHED DEMOGRAPHICS ARE PLACED ON HOLD AND RESULTS ARE NOT RELEASED. LGC HAS A TEAM THAT MAY CONTACT THE USER AND RELEASE RESULTS THAT WERE PLACED ON HOLD (E.G., IN CASE OF TYPOS). HOWEVER, ON 15MAR2022 LGC HAS BECOME AWARE THAT ALL THREE MITIGATION PROCESSES ABOVE MENTIONED FAILED AND THE NEGATIVE RESULT FOR HEPATITIS C FROM THE USER ASSOCIATED WITH THE MDR 3015209536-2022-00001 (PATIENT ID: (B)(6) WAS RELEASED TO THE USER ASSOCIATED WITH THE MDR (MDR 3015209536-2022-00002 / PATIENT ID: (B)(6). IN ADDITION, LGC IS AWARE OF ONE SAMPLE THAT WAS RETURNED FROM ONE USER (MDR 3015209536-2022-00003 / PATIENT ID: (B)(6) THAT WAS A REACTIVE RESULT FOR HEPATITIS C, HOWEVER, THE RESULT WAS NOT RELEASED TO THE USER DUE TO THE MISMATCHED DEMOGRAPHICS. AN INVESTIGATION WAS CARRIED OUT THROUGH WHICH A PROCESS RELATED ISSUE WAS IDENTIFIED DURING THE DISPATCH OF THE SAMPLE COLLECTION KITS WHICH LED ONE USER RECEIVING THE KIT WITH A BAR CODE THAT WAS ASSOCIATED WITH ANOTHER USER'S REGISTRATION IN OUR SYSTEM. A CAPA WAS OPENED TO INVESTIGATE THE ROOT CAUSE OF THE ISSUE AND IMPLEMENT CORRECTIVE/PREVENTIVE ACTIONS THROUGH OUR QMS. HEPATITIS C INFECTION IS TYPICALLY ASYMPTOMATIC. IT CAUSES LIVER INFLAMMATION AND IN MORE THAN 50% OF THE AFFECTED POPULATION IT WILL RESULT IN CHRONIC LIVER INFECTION. CHRONIC HEPATITIS C CAN LEAD TO SERIOUS AND LIFE-THREATENING LIFE CONDITIONS SUCH AS CIRRHOSIS AND/LIVER CANCER. WHEN SYMPTOMS OCCUR, THEY ARE TYPICALLY IN THE SETTING OF ADVANCED LIVER DISEASE. THEREFORE, THE RISK TO HEALTH TO THESE USERS HAS BEEN ASSESSED AS: - MDR 3015209536-2022-00003 / PATIENT ID: (B)(6): POTENTIAL DELAY IN RECEIVING TREATMENT AND/OR POTENTIAL DELAY IN DIAGNOSIS (REACTIVE RESULT THAT WAS NOT RELEASED TO THE USER). - MDR 3015209536-2022-00002 / PATIENT ID: (B)(6): MISLEADING NEGATIVE RESULTS WHICH MAY LEAD THE USER TO NOT PURSUE FURTHER TESTING. LGC HAS CARRIED OUT A RISK ASSESSMENT THROUGH WHICH THE SEVERITY HAS BEEN DEEMED AS "CRITICAL" (E.G., ACUTE LIVER FAILURE ON THE BACKGROUND OF CIRRHOSIS WHICH REQUIRES MEDICAL INTERVENTION TO PREVENT A LIFE-THREATENING CONDITION) AND THE PROBABILITY OF HAZARDOUS SITUATION LEADING TO HARM WAS ASSESSED AS "LIKELY" (INJURY MAY OCCUR). THERE WAS NO SERIOUS INJURY REPORTED BUT THE RECURRENCE OF THIS MALFUNCTION COULD INDIRECTLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THEREFORE, LGC DEEMS THESE COMPLAINTS REPORTABLE. NOTE: THE SUBMISSION OF THIS REPORT WAS DONE VIA POST ON 14MAR2022. LETSGETCHECKED RECEIVED IT BY POST ON 09MAY2022 RETURNED FROM THE FDA WITH A NOTE THAT SUBMISSION HAD TO BE THROUGH WEBTRADER. WE INITIATED SETTING UP THE PRODUCTION ACCOUNT ON 09MAY2022 AND THIS IS BEING SUBMITTED NOW DUE TO DELAY TO SET UP THE PRODUCTION ACCOUNT FOR FIRST SUBMISSIONS BY THE COMPANY. THE PRODUCTION ACCOUNT WAS GRANTED ON 06JUL2022.

    Description of Event or Problem · 0

    THE USER RECEIVED A LETSGETCHECKED SAMPLE COLLECTION KIT THAT WAS LINKED TO ANOTHER USER/DETAILS IN OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504525 BLOOD SAMPLE COLLECTION KIT 300 LH BLOOD SAMPLE COLLECTION PQD PRIVAPATH DIAGNOSTICS LTD LGC-3550-6396-7435 09012024 00850024881341

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female