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 2019-02-15 for PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LWWS manufactured by Medtronic Minimed.
[136459559]
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
[136459560]
It was reported that the customer's insulin pump had received motor error. The customer? S blood glucose level was 10 mmol/l. The customer reported that they received a motor error alarm. Customer was able to successfully clear the alarm. Customer was unable to complete pump rewind. The customer reported that the drive support cap was normal. The customer was advised the pump will need to be replaced. The customer was advised to discontinue use of the pump and was advised to refer to back up plan, per health care professional instructions. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
[141437934]
Motor error alarm during rewind due to motor encoder signal out of phase. Unable to perform any tests due to motor error alarm.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032227-2019-01514 |
| MDR Report Key | 8346014 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-15 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-02-11 |
| Date Mfgr Received | 2019-04-05 |
| Device Manufacturer Date | 2014-03-26 |
| Date Added to Maude | 2019-02-15 |
| 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 | PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LWWS |
| Generic Name | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR |
| Product Code | OYC |
| Date Received | 2019-02-15 |
| Returned To Mfg | 2019-03-16 |
| Model Number | MMT-722LWWS |
| Catalog Number | MMT-722LWWS |
| Lot Number | A000117169 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-15 |