BEUDAMED
    FDA Recall Open, Classified

    Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)

    Recall: Z-0683-2019 · Initiated October 3, 2018

    Recall

    Recall Number
    Z-0683-2019
    Event Number
    81246
    Firm
    Medtronic Inc.
    FEI Number
    3003166194
    Product Code
    OZO
    Status
    Open, Classified
    Root Cause
    Software design (manufacturing process)
    Initiated
    October 3, 2018
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)

    Reason

    Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.

    Action

    On 10/3/2018, the firm sent an URGENT FIELD SAFETY NOTIFICATION to customers and distributors via email and/or US Postal Service First Class to inform them of reports of occurrences in which insulin pumps with version 4.10 software has failed to make expected audio sounds during alerts, alarms, or sirens. This failure could either cause the alarm volume to be stuck at a 4 (out of 5) level regardless of the personal setting, or it could make no sound. Either of these occurrences could cause the user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts. Consignees are being informed that they are receiving this letter because the firm's records indicate they may have one of the potentially affected insulin pumps. The notification further explains, this issue occurs when a specific electronic component in the pump malfunctions. This potential loss of audio could delay the user's response to the underlying reason for the alert, alarm, or siren, which could then lead to possible health and safety risks such as hypoglycemia or hyperglycemia. If this issue occurs with the pump, the audio cannot be permanently repaired or regained. The only way to permanently regain the audio capabilities is to exchange the affected pump with a replacement. Even if the pump has the audio issue, it will continue to deliver insulin as expected. Loss of the Vibrate feature has not been reported to occur as part of the above audio failure mode. If a customer has a pump that contains the specific electronic component, and the pump passes the Audio Beep test described below, there is still a chance that the pump may lose its audio capabilities at some future date. Customers are instructed to: What you should do: 1. If you have not already done so, enable the Vibrate feature on your pump. Even if the Audio Beep test passes, you should enable the Vibrate feature (in addition to your Audio feature) since it will add

    Distribution

    US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, VT, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY

    Quantity

    142889