BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-551LNAS

    MDR report key: 6971873 · Received October 24, 2017

    Report

    Report Number
    2032227-2017-59969
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    October 9, 2017
    Report Date
    February 27, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169507739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. INSULIN PUMP PASSED ALL FUNCTIONAL TESTING, INCLUDING IDLE CURRENT TEST, RUN CURRENT TEST, SELF-TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/COMPROMISED FORCE SENSOR SYSTEM TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST, DISPLACEMENT ACCURACY TEST AT 0.08750 INCHES AND REWIND TEST. NO OVER DELIVERY ANOMALY NOTED. INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW AND 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND OVER DELIVERY. THE CUSTOMER HAD SYMPTOMS SUCH AS ANXIETY, SWEATING, AND CONFUSION. THE CUSTOMER WAS TREATED FOR THE LOW BLOOD GLUCOSE WITH APPLE JUICE AND PBJ SANDWICH. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 43 MG/DL AT THE TIME OF THE INCIDENT AND CURRENT BLOOD GLUCOSE LEVELS WAS 196 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WAS OVER DELIVERING INSULIN. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDS TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750884 530G INSULIN PUMP MMT-551LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551LNAS A4551LNASJ 00643169507739

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other