BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL

    MDR report key: 6802651 · Received August 17, 2017

    Report

    Report Number
    2032227-2017-37826
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    June 23, 2010
    Report Date
    January 16, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    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. 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.

    Additional Manufacturer Narrative · 1

    PUMP RECEIVED WITH BLANK DISPLAY, PROBLEM ISOLATED TO INTERFACE BOARD. NO AUDIO/BEEP ANOMALY NOTED DURING TESTING. UNABLE TO CONFIRM ALARM AND UNABLE TO PERFORM ANY TESTS DUE TO BLANK DISPLAY. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, STAINED ADDRESS/SERIAL NUMBER LABEL AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED.

    Description of Event or Problem · 1

    (B)(4). INITIAL NOTES: I HAVE A LOANER PUMP. INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CUSTOMER STATES THAT SHE HAS HAD THE LOANER PUMP FOR ABOUT 2 WEEKS AND TONIGHT ABOUT 45 MINS AGO THE PUMP STARTED MAKING A HIGH PITCH NOISE AND GAVE A13 ERROR. CUSTOMER STATES THAT SHE TOOK THE BATTERY OUT THE PUMP TO STOP THE NOISE. A-XX/E-XX ALARM T/S PER DOP114-950. CUSTOMER STATES THE ALARM RECEIVED WAS A13. EXPL ALARM AND POSSIBLE CAUSES. ALARM DID NOT OCCUR DURING THE REWIND/PRIME SEQUENCE. CUSTOMER STATES THAT THE SCREEN IS BLANK SO WENT TO BLANK DISPLAY CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: WENT TO BLANK DISPLAY T/S INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CUSTOMER STATES THAT THE PUMP SCREEN IS BLANK. BLANK DISPLAY T/S PER DOP114-950. EXPLAINED THE POSSIBLE CAUSES OF BLANK DISPLAY. ADV TO DISCONNECT FROM THE PUMP. CUSTOMER IS NOT CALLING BACK AFTER RECEIVING A NEW BATTERY CAP. INQUIRED IF THE PUMP SHOWS SIGNS OF PHYSICAL DAMAGE. FOUND: NO . INQUIRED IF THE PUMP HAS BEEN DROPPED OR BUMPED. FOUND: NO . INQUIRED IF THE PUMP HAS BEEN EXPOSED TO MOISTURE. FOUND: NO . BATTERY IN THE PUMP IS A (B)(6) ALKALINE BATTERY. TYPE OF BATTERY IN USE: ENERGIZER. CUSTOMER STATES THE CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED. CUSTOMER STATES BATTERY COMPARTMENT IS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING IS NEITHER DAMAGED NOR CORRODED. CUSTOMER HAS A NEW (B)(6) ALKALINE BATTERY TO TEST WITH THE PUMP. ADV THE CUSTOMER TO INSERT THE NEW (B)(6) ALKALINE BATTERY. QUESTION - DID THE DISPLAY RETURN? RESPONSE: CUSTOMER STATES THAT THE SCREEN IS NOT COMING UP JUST A HIGH PITCH NOSIE. ADV TO REMOVE BATTERY FOR 10 MINUTES. ADV A BATTERY OUT LIMIT ALARM WILL OCCUR AFTER THE PUMP REST. ADV CUSTOMER TO CLEAN THE BATTERY CAP CONTACT WITH A COTTON SWAB AND IPA (ISOPROPYL ALCOHOL). ADV THAT IF NO ISOPROPYL ALCOHOL IS AVAILABLE TO USE AN ALCOHOL WIPE OR DRY COTTON SWAB. ADV TO ALLOW AT LEAST ONE MINUTE FOR THE BATTERY CONTACTS TO DRY. ADV TO INSERT A NEW (B)(6) ALKALINE BATTERY (RECOMMENDED ENERGIZER). CHECKED TO MAKE SURE CUSTOMER IS INSERTING BATTERY CORRECTLY. CUSTOMER STATES THE DISPLAY DID NOT RETURN. ADV THE PUMP WILL NEED TO BE REPLACED. ADV TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HCP'S INSTRUCTIONS. EXPL OOW RPL POLICY. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: CUSTOMER WILL RECEIVE A COT PUMP AND WILL SEND BACK THE OOW PUMP. SHIP: 1 COT PUMP, / RETURN: 1 COT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582932 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAL A4523LNALJ 00643169513846

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR