BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183175 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40123
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATIONS. THE DEVICE PASSED THE SELF TEST, ERROR ALARM TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST AND MOTOR TEST. NO MOTOR ERROR ALARMS NOTED. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. THE SENSOR FEATURE WAS WORKING PROPERLY. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED A MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 419 MG/DL, WHICH HE STATES CONTINUES TO RISE EVEN AFTER TREATING HIGH BLOOD GLUCOSE. CUSTOMER STATES HE IS TAKING HYDROCODONE DUE TO A PREVIOUS SURGERY. CUSTOMER WAS ADVISED TO CONSULT HEALTH CARE PROFESSIONAL FOR DRUG INTERACTION. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660773 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR