BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DROPLET PEN NEEDLE

    MDR report key: 24781234 · Received April 3, 2026

    Report

    Report Number
    9613304-2026-00010
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Report Date
    March 18, 2026
    Manufacturer
    HTL-STREFA S.A.
    Product Code
    FMI
    UDI-DI
    00857273002091
    PMA / PMN Number
    171982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE SUBMITTED NOTIFICATION, THERE WAS REPORTED PRIMING PROBLEMS. CUSTOMER STATED SEVERAL PEN NEEDLES FAILED TO DISPENSE INSULIN. THE USER COMPLETED THE INJECTION USING A REPLACEMENT PEN NEEDLE AND REPORTED NO ADVERSE HEALTH CONSEQUENCES. THE PEN INJECTORS USED WAS LANTUS SOLOSTAR PEN INJECTOR. THE INSULIN DOSES ARE CLOSELY CORRELATED WITH THE PATIENT'S CONDITION AND GLYCAEMIC CONTROL. WHETHER THE PATIENT HAS RECEIVED ADEQUATE DOSES OF INSULIN CAN BE ASSESSED THROUGHOUT THE DAY DURING GLUCOSE MEASUREMENTS. CONSIDERING THE ABOVE, THE ADMINISTRATION OF INSULIN IS NOT INDIFFERENT (GLUCOSE MONITORING) TO THE PATIENT AND CANNOT BE OVERLOOKED. CONCERNS ABOUT THE ADMINISTRATION OF A FULL OR INCOMPLETE DOSE OF INSULIN ARE MONITORED BY PATIENTS ON AN ONGOING BASIS, THEREFORE THE RISK OF SERIOUS HEALTH COMPLICATIONS IS LOW. GLYCAEMIC CONTROL IS THE MAIN MEASURE OF DIABETIC STATUS ASSESSMENT AND IS AN IMPORTANT PARAMETER OF DAILY THERAPY. HISTORY OF PREVIOUS, SIMILAR EVENTS SHOW THAT A LEVEL OF CONFIRMED DEFECTS OF PRODUCT IN COMPARISON TO QUANTITY SOLD IS NEGLIGIBLE, THE RATIO OF THE CONFIRMED COMPLAINTS IS ON VERY LOW LEVEL. THE DEFECT WAS OBSERVED DURING EVALUATION OF ARCHIVAL SAMPLE - 12 PEN NEEDLE WITH LACK OF PATENCY WERE FOUND. INFORMATION ABOUT DEFECT WAS IMMEDIATELY FORWARDED TO APPROPRIATE DEPARTMENT. CAPA ACTIONS HAS BEEN INTRODUCED TO THE COMPLAINED PROBLEM. PRODUCTION PROCESS HAS BEEN VERIFY. NO DEFECTS IN DHR REVIEWED. ALTHOUGH NO HARM OCCURRED IN THIS EVENT, BLOCKAGE OF A PEN NEEDLE REPRESENTS A MALFUNCTION OF THE DEVICE, AS IT FAILED TO PERFORM ITS INTENDED FUNCTION OF ENABLING INSULIN DELIVERY. IF SUCH A MALFUNCTION WERE TO RECUR AND REMAIN UNDETECTED, IT COULD POTENTIALLY RESULT IN UNDER-DELIVERY OR NON-DELIVERY OF INSULIN, WHICH MAY LEAD TO SERIOUS DETERIORATION OF HEALTH. BASED ON THE ABOVE, DESPITE THE ABSENCE OF PATIENT HARM, THE EVENT IS ASSESSED AS A REPORTABLE MALFUNCTION UNDER FDA MDR REQUIREMENTS.

    Description of Event or Problem · 0

    ON (B)(6) 2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES HAVE FAILED TO DISPENSE INSULIN. SHE HAS 10 FAILURES OUT OF HER CURRENT BOX. SHE USES LANTUS SOLOSTAR INJECTION PEN. SHE CONFIRMED THAT SHE FOLLOWS THE IFU AND DID NOT SUFFER ANY MIS DOSING OR HEALTH CONSEQUENCE. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114089 DROPLET PEN NEEDLE PEN NEEDLE FMI HTL-STREFA S.A. 32G X 4MM F58A4 00857273002091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female