BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554WWH

    MDR report key: 9619991 · Received January 23, 2020

    Report

    Report Number
    3004209178-2020-58866
    Event Type
    Malfunction
    Date Received
    January 23, 2020
    Date of Event
    February 4, 2019
    Report Date
    January 23, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169376045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO CORRODED BATTERY TUBE SPRING CONTACT AND CORRODED BATTERY TUBE. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO BLANK DISPLAY. INSULIN PUMP RECEIVED WITH CRACKED LCD WINDOW AND CRACKED CASE DISPLAY WINDOW CORNER. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    ON (B)(6) 2019 16:00:08 PST ICE BATCH USER (BATCH_ICE) PHONE (B)(6). COMPLAINT: (B)(4). COMPLAINT STATUS: IN PROCESS. MDT INITIAL CONTACT: (B)(4). CRACK IN CASE. PUMP NOT BUMPED OR DROPPED. CRACK IS SEEN ON: OVER DISPLAY. DRIVE SUPPORT CAP APPEARS TO BE DAMAGED: NO. NO CAR ACCIDENT. CUSTOMER DOESN'T KNOW HOW IT HAPPENED. SENDING REPLACEMENT. ASKED CUSTOMER VERBALLY AND IN WRITTEN FORM TO RETURN BROKEN PUMP FOR ANALYSIS. (B)(6). BATCH -(B)(4). ON (B)(6) 2019 (B)(4). 17 PST ICE BATCH USER (BATCH_ICE) (B)(4) COMPLAINT STATUS: COMPLETED MDT INITIAL CONTACT: (B)(4): CUSTOMER DID NOT RECEIVE A REPLACEMENT YET. CUSTOMER WILL RETURN BROKEN PUMP LATER. ON 25.02.19 KLH CRACK IN CASE. PUMP NOT BUMPED OR DROPPED. CRACK IS SEEN ON: OVER DISPLAY. DRIVE SUPPORT CAP APPEARS TO BE DAMAGED: NO. NO CAR ACCIDENT. CUSTOMER DOESN'T KNOW HOW IT HAPPENED. SENDING REPLACEMENT. ASKED CUSTOMER VERBALLY AND IN WRITTEN FORM TO RETURN BROKEN PUMP FOR ANALYSIS. COUNTRY: (B)(6) 2019 WARRANTY START: 11/26/2014 WARRANTY END: 11/25/2018 BATCH - (B)(4). ON 03/26/2019 16:11:40 PST ICE BATCH USER (BATCH_ICE (B)(4) HASSD2 GFE: FIRST REMINDER LETTER SENT ON THE 26TH MARCH 2019. ON 26.03.19 DDH GFE: CUSTOMER DID NOT RECEIVE A REPLACEMENT YET. CUSTOMER WILL RETURN BROKEN PUMP LATER. ON 25.02.19 KLH CRACK IN CASE. PUMP NOT BUMPED OR DROPPED. CRACK IS SEEN ON: OVER DISPLAY. DRIVE SUPPORT CAP APPEARS TO BE DAMAGED: NO. NO CAR ACCIDENT. CUSTOMER DOESN'T KNOW HOW IT HAPPENED. SENDING REPLACEMENT. ASKED CUSTOMER VERBALLY AND IN WRITTEN FORM TO RETURN BROKEN PUMP FOR ANALYSIS. COUNTRY: (B)(6) 2019 WARRANTY START: 11/26/2014 WARRANTY END: 11/25/2018 BATCH - (B)(4). ON 04/15/2019 17:38:01 PST ICE BATCH USER (BATCH_ICE) (B)(4). COMPLAINT STATUS: COMPLETED MDT INITIAL CONTACT: (B)(4), GFE: SECOND REMINDER LETTER SENT ON THE 15TH APRIL 2019. ON 15.04.19 KLH GFE: FIRST REMINDER LETTER SENT ON THE 26TH MARCH 2019. ON 26.03.19 DDH GFE: CUSTOMER DID NOT RECEIVE A REPLACEMENT YET. CUSTOMER WILL RETURN BROKEN PUMP LATER. ON 25.02.19 KLH CRACK IN CASE. PUMP NOT BUMPED OR DROPPED. CRACK IS SEEN ON: OVER DISPLAY. DRIVE SUPPORT CAP APPEARS TO BE DAMAGED: NO. NO CAR ACCIDENT. CUSTOMER DOESN'T KNOW HOW IT HAPPENED. SENDING REPLACEMENT. ASKED CUSTOMER VERBALLY AND IN WRITTEN FORM TO RETURN BROKEN PUMP FOR ANALYSIS. COUNTRY: (B)(6) INPUT DATE: 02/04/2019 WARRANTY START: 11/26/2014 WARRANTY END: 11/25/2018 BATCH - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84999 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554WWH PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWH B3554WWHJ 00643169376045

    Patients

    Seq Age Sex Outcome Treatment
    1