BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4241741 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50663
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    November 5, 2014
    Report Date
    March 29, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING, INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. NO EXCESSIVE NO DELIVERY ALARM WAS NOTED. ALL OF THE BUTTONS FUNCTIONED PROPERLY. NO DAMAGE WAS NOTED ON THE KEYPAD TRACES DURING THE VISUAL INSPECTION AND NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP WAS MONITORED WITH 2 UNIT BASAL RATE AND MONITORED FOR THREE DAYS. THE BASALS AND BOLUSES WERE DELIVERED AND PROPERLY RECORDED IN THE HISTORY AND DAILY TOTALS. NO UNEXPECTED LOW SUSPEND ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-50665.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED WITH THIS REPORT. THE LCD CONNECTOR WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS 2 WEEKS PRIOR. THE BLOOD GLUCOSE READING AT TIME OF ADMITTANCE WAS UNKNOWN; THE SENSOR GLUCOSE READING WAS 52 MG/DL. ABOUT 2 DAYS PRIOR, IT WAS ALSO REPORTED THAT THE INSULIN PUMP'S THRESHOLD SUSPEND FEATURE WAS TRIGGERED BY AN INACCURATE SENSOR GLUCOSE READING. THE CUSTOMER NOTED THAT THE SENSOR GLUCOSE READING WAS 70 MG/DL, COMPARED WITH THE BLOOD GLUCOSE READING OF 115 MG/DL. SHE STATED THAT SHE MIGHT HAVE OVER-BOLUSED LEADING UP TO THE EVENT. THE BLOOD GLUCOSE READING WAS 209 MG/DL, WHICH SHE TREATED WITH THE INSULIN PUMP. SHE NOTED THAT SHE HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR A FEW WEEKS. THE RESERVOIR SHOWED THE SAME AMOUNT OF INSULIN AS WAS SHOWN ON THE STATUS SCREEN. SHE REPORTED THAT SHE HAD MADE ADJUSTMENTS TO THE DEVICE SETTINGS AND WAS ON ORAL MEDICATIONS. NO DELIVERY AND BUTTON ERROR ALARMS WERE FOUND IN THE ALARM HISTORY; ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723943 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization