BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142291 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33447
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT. THE INSULIN PUMP WAS MONITORED FOR 72 HOURS AND NO UNEXPECTED AUDIO ANOMALY WAS NOTED. THE BATTERY CAP SCREWED IN PROPERLY AND NO PHYSICAL DAMAGE WAS NOTED TO THE BATTERY CAP. NO COSMETIC DAMAGE WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND THAT THE INSULIN PUMP KEPT BEEPING THROUGHOUT THE DAY. THE CUSTOMER STATED THAT SHE HAD A BLOOD GLUCOSE READING OF 500 MG/DL TWO MONTHS PRIOR. SHE NOTED ANOTHER HIGH BLOOD GLUCOSE READING OF 400 MG/DL THE MONTH PRIOR, AS WELL AS ONE ON THE MORNING OF THE CALL. THE MOST RECENT BLOOD GLUCOSE READING WAS 152 MG/DL. SHE STATED THAT SHE WAS NOT HAPPY WITH THE INSULIN PUMP AND THAT THE BATTERY CAP WAS NOT SCREWING IN PROPERLY, AS WELL. UPON TROUBLESHOOTING, IT WAS FOUND THAT THE INSULIN PUMP DID VIBRATE DURING THE SELF TEST. THE CUSTOMER STATED THAT SHE THOUGHT THE BATTERY CAP OR RESERVOIR MIGHT BREAK WHEN SHE TIGHTENS THE CAP. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622082 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR