MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-18 for CARELINK PERSONAL MMT-7333 manufactured by Medtronic Minimed.
[83204154]
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
[83204155]
It was reported via phone call on (b)(6) 2017, that the insulin pump alarmed compromised force sensor system and insulin squirted out of the tubing during manual prime. The customer was a (b)(6) female and (b)(6). The customer? S blood glucose level at the time of the incident was 210 mg/dl. The customer was disconnected during prime. The drive support cap was not damaged. It was advised to discontinue the use of the device and to revert to the back-up plan. The insulin pump will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
[98092004]
The initial report was created in error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032227-2017-38193 |
| MDR Report Key | 6805981 |
| Date Received | 2017-08-18 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-07-22 |
| Date Mfgr Received | 2017-07-22 |
| Date Added to Maude | 2017-08-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 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 | 0 |
| Brand Name | CARELINK PERSONAL MMT-7333 |
| Generic Name | CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE |
| Product Code | PHV |
| Date Received | 2017-08-18 |
| Model Number | MMT-7333 |
| Catalog Number | MMT-7333 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2017-08-18 |