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 2019-11-29 for 640G INSULIN PUMP MMT-1711K manufactured by Medtronic Puerto Rico Operations Co..
[173565894]
(b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[173565895]
It was reported that their insulin pump had critical pump error and hardware low level failures error. The customer? S blood glucose was 9. 4 mmol/l at the time of incident. Customer reported that they received the open book image on the insulin pump screen. The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan. The insulin pump will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
[182045621]
Device received with a critical pump error and a pump error 35 found in the formatted history file. Unable to perform functional tests including displacement, rewind, prime or seating, basic occlusion, force sensor, occlusion, sleep current measurement, and active current measurement, or self tests due to the critical pump error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032227-2019-125219 |
| MDR Report Key | 9391413 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-29 |
| Date of Report | 2019-11-29 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2019-11-26 |
| Device Manufacturer Date | 2018-12-09 |
| Date Added to Maude | 2019-11-29 |
| 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 | CEIBA NORTE IND. PARK #50 ROAD |
| Manufacturer City | JUNCOS 00777-386 |
| Manufacturer Postal | 00777-3869 |
| Manufacturer Phone | 8185464805 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | CEIBA NORTE IND. PARK #50 ROAD |
| Manufacturer City | JUNCOS 00777-386 |
| Manufacturer Postal Code | 00777-3869 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 640G INSULIN PUMP MMT-1711K |
| Generic Name | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR |
| Product Code | OYC |
| Date Received | 2019-11-29 |
| Model Number | MMT-1711K |
| Catalog Number | MMT-1711K |
| Lot Number | HG30UPS |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | CEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777-386 00777-3869 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-29 |