BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO

    MDR report key: 4272545 · Received October 9, 2014

    Report

    Report Number
    3003442380-2014-00082
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    October 9, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K051264
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFT CANNULA WAS KINKED. DURING MANUFACTURING OF THE CANNULA PART THE SOFT CANNULA IS KEPT STRAIGHT BY THE INTRODUCER NEEDLE. HOWEVER, IF THE INTRODUCER NEEDLE IS BENT DURING HANDLING AND PACKAGING OF THE INFUSION SET, THIS MAY AFFECT THE SOFT CANNULA CAUSING IT TO KINK. DURING USE IN GENERAL AND SPECIFICALLY DURING INSERTION THE PATIENT MAY ACCIDENTALLY KINK THE SOFT CANNULA. USED DEVICE: A VISUAL INSPECTION AND TESTS FOR FLOW LEAK AND VENTILATION TO PCC CONNECTOR WERE PERFORMED ON THE RETURNED USED DEVICES (2 SETS). SOFT CANNULAS WERE KINKED (AT THE TIP) (2/2); AND PCC CONNECTOR NEEDLES WERE CLOGGED (BY INSULIN) (2/2). LEAK AND VENTILATION TO PCC CONNECTOR TEST RESULTS WERE WITHIN SPECIFICATIONS. UNUSED DEVICES: NOT TESTED. REFERENCE SAMPLES: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND VENTILATION TO THE PCC RESERVOIR CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER HAD TO BE HOSPITALIZED FOR DKA AND SHE MENTIONED SHE KEPT GETTING BENT CANNULAS USING THE MIOS. SHE AND HER HUSBAND BOTH INSERTED MIOS. HER BLOOD GLUCOSE CONCENTRATIONS KEPT GOING UP AND NEVER CAME DOWN. SHE USED SIX DIFFERENT SETS BUT ONLY HAS TWO TO SEND BACK. SHE IS THIN BUT HER SITES ARE IN GOOD SHAPE EXCEPT FOR NOW AFTER THIS EXPERIENCE. SHE SAID SHE NOTICED INSULIN SITTING ON HER SKIN WHICH MAY BE WHY SHE DIDN'T GET ANY DELIVERY ALARMS. WHEN WE TESTED THE PUMP FOR NO DELIVERY IT TOOK UNTIL 4.8 ONE TIME AND 4.7 A SECOND TIME TO ALARM. DECIDED TO REPLACE THE PUMP BASED ON THIS LONG TIME BEFORE IT ALARMED. SPOKE TO (B)(4) WHO SAID TO DOCUMENT THE SETS UNDER BENT CANNULA AND THE PUMP UNDER THE HOSPITALIZED BLOOD GLUCOSE CONCENTRATIONS. SENDING 1 BOX OF MMT-943 AND RETURNING 2 MMT-943. ADVISED CUSTOMER TO USE A FEW OF THE ONES I SENT HER AND SEE HOW HER BLOOD GLUCOSE CONCENTRATIONS ARE AND THEN TRY SOME OF HER ORIGINAL LOT NUMBER AND IF SHE EXPERIENCES HIGH BLOOD GLUCOSE CONCENTRATIONS SUDDENLY TO CALL TO GET THOSE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634228 MIO FPA UNOMEDICAL A/S MMT-943 5054564/5050541

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization