MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-17 for ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT 10401008 10101018 manufactured by Accelerate Diagnostics, Inc..
| Report Number | 3010671651-2020-00001 |
| MDR Report Key | 9838624 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. CONSTANCE BRIDGES |
| Manufacturer Street | 3950 S COUNTRY CLUB RD. #470 |
| Manufacturer City | TUCSON, AZ |
| Manufacturer Country | US |
| Manufacturer Phone | 6529224 |
| Manufacturer G1 | ACCELERATE DIAGNOSTICS, INC. |
| Manufacturer Street | 3950 S COUNTRY CLUB RD. #470 |
| Manufacturer City | TUCSON, AZ |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT |
| Generic Name | ACCELERATE PHENO SYSTEM |
| Product Code | PRH |
| Date Received | 2020-03-17 |
| Model Number | 10401008 |
| Catalog Number | 10101018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCELERATE DIAGNOSTICS, INC. |
| Manufacturer Address | 3950 S. COUNTRY CLUB RD. #470 TUCSON, AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |