BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4202648 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-24019
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND DUE TO CORRODED MOTOR ASSEMBLY. INSULIN PUMP WAS UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MOTOR ANOMALY AND UNABLE VERIFY PRIME ALARM. NO TRACES OF MOISTURE WERE NOTED AT ELECTRONIC ASSEMBLIES PER VISUAL INSPECTION. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED BATTERY TUBE THREADS AND BELT CLIP SLOT.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MFG SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE PER VARIANCE 5. CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED DURING REWIND. CUSTOMER'S BLOOD GLUCOSE WAS 177 MG/DL. CUSTOMER REPORTED THAT CUSTOMER HAD TO GO INTO THE WATER TO SAVE ONE OF THE CHILDREN. THE DEVICE GOT A LITTLE WET. CUSTOMER STATED HE WAS CHANGING HIS INFUSION SET AND THE DEVICE ALARMED. THEN IT ALARMED AGAIN AFTER CLEARING AND PERFORMING THE REWIND PROCESS ON THE DEVICE. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER DID NOT DROP OR BUMP THE DEVICE PRIOR TO THE ALARM. CUSTOMER WAS ADVISED TO CONTINUE DISCONNECTED. CUSTOMER STATED THE DRIVE SUPPORT CAP WAS NORMAL AND HE DID NOT PRESS IT IN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577123 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR