MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for SENSOR MMT-7020C1 GS3 5PK 9L OUS1 manufactured by Medtronic Minimed.
[185913534]
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
Patient Sequence No: 1, Text Type: N, H10
[185913535]
It was reported that the sensor had inaccurate readings that triggered threshold suspend alarm. The customers blood glucose levels were 20. 9 mmol/l and sensor glucose levels were 13. 6 mmol/l at the time of the incident. The customer reported having issues with the sensor. The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range. The sensor will not return for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032227-2020-102092 |
| MDR Report Key | 9908703 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2019-09-05 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GERWIN DE GRAAFF |
| Manufacturer Street | 18000 DEVONSHIRE ST. |
| Manufacturer City | NORTHRIDGE CA 913251219 |
| Manufacturer Country | US |
| Manufacturer Postal | 913251219 |
| Manufacturer Phone | 8185464805 |
| Manufacturer G1 | MEDTRONIC MINIMED |
| Manufacturer Street | 18000 DEVONSHIRE ST. |
| Manufacturer City | NORTHRIDGE CA 913251219 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 913251219 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSOR MMT-7020C1 GS3 5PK 9L OUS1 |
| Generic Name | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL |
| Product Code | OZP |
| Date Received | 2020-03-31 |
| Model Number | MMT-7020C1 |
| Catalog Number | MMT-7020C1 |
| Lot Number | I059 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MINIMED |
| Manufacturer Address | 18000 DEVONSHIRE ST. NORTHRIDGE CA 913251219 US 913251219 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |