BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4221754 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46706
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER TRIED TO BOLUS USING THE PUMP, BUT HAS BEEN UNABLE TO BRING HER BLOOD GLUCOSE LEVEL UNDER CONTROL. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 600 MG/DL. CUSTOMER HAD THE FOLLOWING SYMPTOMS: NAUSEA AND HEADACHE. CUSTOMER DID NOT CONTACT HER HEALTH CARE PROFESSIONAL. CUSTOMER STATED THAT SHE HAD A BACKUP PLAN AND TOOK AN INJECTION OF INSULIN WHILE ON THE PHONE. CUSTOMER DISCONNECTED AT THE QUICK RELEASE. CUSTOMER FOUND NO AIR BUBBLES IN THE TUBING. CUSTOMER RAN A MANUAL PRIME AND STATED THAT THE INSULIN DID EXIT THE TUBING. CUSTOMER'S SETTINGS WERE REVIEWED AND BASAL RATES WERE CORRECTED. CUSTOMER WILL BE SENT A TUBING CLAMP TO COMPLETE THE HIGH PRESSURE TEST. CUSTOMER FOUND THAT THE CANNULA WAS BENT BUT NOT OCCLUDED. CUSTOMER WAS ADVISED THAT THE POTENTIAL CAUSE FOR HIGH BLOOD GLUCOSE LEVELS WAS THE BENT CANNULA. CUSTOMER WAS ADVISED TO DO AN IMMEDIATE SET CHANGE AND TO CALL BACK WHEN SHE RECEIVES THE TUBING CLAMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702500 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR