BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO

    MDR report key: 3448934 · Received October 29, 2013

    Report

    Report Number
    3003442380-2013-00008
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 29, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. IT IS PENDING INVESTIGATION BECAUSE OF CALIBRATION OF TEST EQUIPMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER NAME: (B)(6) DATE OF BIRTH: (B)(6) 2003, REPORTED BY: (B)(6), RELATION: MOTHER. DOCTOR/HOSPITAL: (B)(6). TROUBLESHOOTING NOTES: INITIAL NOTES: BG = 8.9 MMOL/L. CALLER WISHED TO REPORT THAT CUSTOMERS MIO HAVE NEEDLES IN CERTAIN MIO OF THE LOT, LOT # 5001212, THAT ARE EXTRAORDINARILY LONGER THAN USUAL AND CAUSING MUCH PAIN AND DISTRESS TO THE CUSTOMER WHO IS A CHILD. SOME SETS IN LOT ARE NORMAL SIZE THOUGH. ASSISTANCE PROVIDED: ESCALATED TO THE LOCAL BRITISH OFFICE THIS COMPLAINT TO SEE ABOUT AN EXCHANGE VIA A GCN FORM. ADVISED BACKUP PLAN PER HEALTH CARE PROVIDER IF NEEDED. SEE GCN NOTE. SEND NOTHING FOR NOW/ RETURN NOTHING FOR NOW. REASON CODE: GA13 - NEEDLE ANOMALY INCIDENT DATE: (B)(6) 2013. MATERIAL NO.: MMT-943. SN/LOT NO.: (B)(4), BG: 8.9 MMOL/L, SOLUTION CATEGORY: TROUBLESHOOTING ONLY, PRODUCT REPLACEMENT: NONE RMA: N/A, SENDING: NA, RETURNING: NA, (B)(6). BATCH - 5001212.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554517 MIO INSET/MIO AZUL FPA UNOMEDICAL A/S MMT-943 5001212

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization