Recall Z-0683-2019 ยท OZO Automated Insulin Dosing , Threshold Suspend
Medtronic Inc.
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
| Date | Oct 3, 2018 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design (manufacturing process) |
| 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 wit |
| Quantity | 142889 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.