BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLET®

    MDR report key: 18247500 · Received December 1, 2023

    Report

    Report Number
    1810909-2023-00259
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 19, 2023
    Report Date
    March 3, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    QRL
    UDI-DI
    05016003657900
    PMA / PMN Number
    K220633
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTIONS A2 AND A4 AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE MODEL # (D4) WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE MICROLET LANCETS WAS PERFORMED AT THE SUPPLIER SITE, HTL. UPON INVESTIGATION, IT WAS FOUND THAT DURING THE PRODUCTION PHASE, RAW NEEDLES ARE SEPARATED FROM THE FINISHED PRODUCT (NEEDLES IN PLASTIC MOULDING) BY A SEPARATOR, WHICH HAS A VIBRATING DRUM WITH HOLE/SLOTS. THE PROBABLE CAUSE OF RAW NEEDLES NOT BEING SEPARATED FROM THE FINISHED PRODUCT COULD BE PLASTIC PARTICLES, WHICH WERE DEPOSITED IN THE HOLES/SLOTS AND THUS PREVENTED PROPER OPERATION OF THE SEPARATOR. IN ORDER TO INCREASE THE EFFICIENCY OF SEPARATION OF NEEDLES, A GRATE HAS BEEN ADDED DURING THE PRODUCTION PHASE WHICH PREVENTS THE REINTRODUCTION OF RAW NEEDLES INTO THE FINISHED PRODUCT.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: SECTIONS D1 (BRAND NAME), D2B (PRODUCT CODE) AND (D4 (MODEL#, CATALOG# AND UDI#) HAVE BEEN UPDATED. MICROLET® LANCETS WITH SKU#: 6579, 510K#: K220633 AND UDI#: (B)(4) WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL (HCP) FROM AUSTRALIA CALLED TO REPORT THAT WHILE ARRANGING THE MICROLET LANCET BOXES THEIR PHARMACY HAD ORDERED, SHE CUT HERSELF ON THE PALM OF HER HAND AND THEN ALSO PRICKED HERSELF ON THE FINGER. ON CLOSER INSPECTION, SHE FOUND A BOX OF MICROLET LANCETS WITH A LANCET STICKING THROUGH THE CORNER OF THE BOX. THE LANCET DID NOT HAVE A PROTECTIVE COVER. SHE REPORTED THE INCIDENT TO HER TERRITORY MANAGER. NO MEDICAL INTERVENTION WAS REQUIRED. REPLACEMENT LANCETS WERE SENT TO THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454169 MICROLET® BLOOD GLUCOSE LANCETS QRL ASCENSIA DIABETES CARE US INC. 6579 D16A1S 05016003657900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female