BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 4993740 · Received August 11, 2015

    Report

    Report Number
    2032227-2015-28969
    Event Type
    Death
    Date Received
    August 11, 2015
    Date of Event
    June 28, 2015
    Report Date
    June 15, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED DOME SWITCH ON ESC AND ACT BUTTONS. THE INSULIN PUMP WAS UNABLE TO PERFORM FUNCTIONAL TEST INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS DUE TO KEYPAD ANOMALY. THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. THE INSULIN PUMP WAS RECEIVED WITH DEPLETED BATTERY IN THE BATTERY TUBE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS PROVIDED BECAUSE THE DEVICE EVALUATION WAS NOT COMPLETED WITH THE FIRST FOLLOW UP MEDWATCH REPORT. THE ADDITIONAL DEVICE EVALUATION DATA IS PROVIDED BELOW: THE INSULIN PUMP HAD A HIGH IDLE CURRENT AND ALARMED DURING THE SELF TEST. THE INSULIN PUMP HISTORY DOWN LOAD SHOWED THAT THE INSULIN PUMP WAS NOT USED BETWEEN THE DATES OF (B)(6), 2015.

    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PUMP WAS RECEIVED WITH DEPLETED ALKALINE BATTERY (ENERGIZER) IN THE BATTERY TUBE. CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. INTERMITTENT BUTTON RESPONSE NOTED. UNABLE TO PERFORM PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS DUE TO KEYPAD ANOMALY. HIGH IDLE CURRENT NOTED. ALARM NOTED DURING SELF TEST. UNABLE TO DETERMINE ROOT CAUSE OF KEYPAD ANOMALY, ALARMS AND HIGH IDLE CURRENT DUE TO PUMP PRESERVATION. PUMP HISTORY DOWNLOAD SHOWS THAT PUMP HAS NOT BEEN USED BETWEEN THE DATES OF (B)(4) 2015 TO (B)(4) 2015. UNIT HAD HIGH IDLE CURRENT AND ALARM DURING SELF TEST DUE TO FAULTY Y1 ON THE RF/B. UNIT HAD INTERMITTENT BUTTON RESPONSE ON THE ESCAPE, ACT, UP ARROW AND DOWN ARROW BUTTONS DUE TO FLATTENED DOME SWITCHES (NO CREASE). DURING VISUAL INSPECTION, THE J2 KEYPAD CONNECTOR ON THE LCD/B WAS FOUND LOCKED PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER WAS ON LIFE SUPPORT. THE CAUSE OF DEATH WAS CARDIAC ARREST. THE CALLER STATED THAT THE CUSTOMER WAS TAKEN TO THE HOSPITAL AFTER COLLAPSING AT HOME. THE CUSTOMER HAD GASTROPARESIS AND HAD ISSUES WITH HER KIDNEYS. THE CALLER WAS UNSURE OF THE CUSTOMER'S EXACT BLOOD GLUCOSE VALUE, AT THE TIME OF DEATH, BUT STATED THAT IT WAS BETWEEN 250 MG/DL AND 300 MG/DL. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER WAS UNSURE HOW LONG THE CUSTOMER HAD BEEN DISCONNECTED FROM THE INSULIN PUMP; SHE HAD DISCONNECTED THE DEVICE PRIOR TO THE INCIDENT OF COLLAPSING, BECAUSE SHE WAS HAVING ISSUES WITH IT. THE CALLER WAS UNSURE WHAT ISSUES. THE CUSTOMER WAS USING SENSORS BUT WAS NOT WEARING ONE AT THE TIME OF DEATH. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527326 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 DA Death