BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    LETSGETCHECKED BLOOD SAMPLE COLLECTION KIT

    MDR report key: 25092256 · Received May 6, 2026

    Report

    Report Number
    3015209536-2026-00001
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 6, 2026
    Manufacturer
    PRIVAPATH DIAGNOSTICS LTD
    Product Code
    PQD
    UDI-DI
    00850024881860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MALFUNCTION OF A LANCET INCLUDED IN THE LETSGETCHECKED BLOOD SAMPLE COLLECTION KIT. USER REPORTED THE LANCET REMOVED A PIECE OF SKIN AND LEFT A PLASTIC FRAGMENT IN THEIR FINGER, WHICH REQUIRED REMOVAL WITH TWEEZERS. REPORTED SYMPTOMS INCLUDED SWELLING, DISCOLORATION, AND A PERSISTENT "HARD SENSATION" AT THE SITE.

    Description of Event or Problem · 0

    THE FOLLOWING IS A SUMMARY OF A REPORTED INCIDENT INVOLVING A LETS GET CHECKED BLOOD SAMPLE COLLECTION KIT (LGC-1048-6404-8594, BATCH #32655, CATALOG #BO43SLGLSFANB). ON (B)(6) 2026, A USER REPORTED AN INJURY SUSTAINED WHILE USING THE PROVIDED LANCET (LOT #2501100, CATALOG #P006114A1, MANUFACTURED BY OWEN MUMFORD LIMITED) IN THE LETSGETCHECKED BLOOD SAMPLE COLLECTION KIT. WHILE ATTEMPTING TO PIERCE THEIR RING FINGER FOR SAMPLE COLLECTION, THE USER STATED THAT THE LANCET REMOVED A SIGNIFICANT PIECE OF SKIN AND LEFT A PLASTIC FRAGMENT EMBEDDED IN THE SITE. THE USER HAD TO REMOVE THIS FRAGMENT USING TWEEZERS. THE USER DESCRIBED THE INJURY AS MODERATE, CITING THE FOLLOWING SYMPTOMS: INITIAL SWELLING AND PURPLE DISCOLORATION LASTING 4-5 DAYS. A PERSISTENT "HARD SENSATION" OR FEELING OF A FOREIGN OBJECT AT THE INJECTION SITE. THE USER INDICATED THEY MAY SEEK FURTHER MEDICAL ATTENTION TO ENSURE NO ADDITIONAL FRAGMENTS REMAIN. BATCH 32655: EXPIRATION DATE 01 SEP 2029 AND LANCET LOT #2501100: EXPIRATION DATE 19 JAN 2030. WE HAVE ATTEMPTED TO OBTAIN FURTHER CLINICAL INFORMATION. HOWEVER, THE USER IS CURRENTLY UNRESPONSIVE. IN OUR LAST SUCCESSFUL CONTACT, THEY CONFIRMED THE DISCOLORATION HAD SUBSIDED, BUT THE PERSISTENT HARD SENSATION REMAINED. MANUFACTURER OF THE LANCET, OWEN MUMFORD LIMITED (FEI: (B)(4) HAS BEEN NOTIFIED. THEY HAVE LOGGED THE INCIDENT AS GBC-26-00476 AND WILL REPORT TO THE FDA SEPARATELY. THE USER HAS NOT YET RETURNED THE LANCET FOR INVESTIGATION, DESPITE MULTIPLE ATTEMPTS BY PRIVAPATH DIAGNOSTICS LTD TO RETRIEVE IT. ONCE THE LANCET MANUFACTURER HAS COMPLETED THEIR INDEPENDENT INVESTIGATION AND PROVIDED THE RESULTS, WE WILL SHARE FURTHER UPDATES REGARDING THE OUTCOME AND OUR FINAL CONCLUSIONS WITH THE FDA. THIS IS THE ONLY COMPLAINT RECEIVED OUT OF 4,500 KITS MANUFACTURED UNDER BATCH 32655 (LANCET LOT #2501100). PRELIMINARY INVESTIGATIONS SUGGEST THIS IS AN ISOLATED INCIDENT [?]POTENTIALLY RELATED TO THE LANCET MANUFACTURER RATHER THAN A BATCH-LEVEL ISSUE. OUR ANALYSIS INDICATES NO FAILURES IN PRIVAPATH'S MANUFACTURING OR DISTRIBUTION PROCESSES. [?] WE WILL CONTINUE TO INVESTIGATE THE MATTER WITH THE LANCET MANUFACTURER AND UPDATE ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447700 LETSGETCHECKED BLOOD SAMPLE COLLECTION KIT BLOOD CONVENIENCE KIT PQD PRIVAPATH DIAGNOSTICS LTD 32655 00850024881860

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other