MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-01 for ROCHE COBAS COBAS E411 manufactured by Roche.
[66597613]
It was discovered that the roche e411 lab machine had incorrect dilution settings programmed for hcg, tsh, and bnp. We reviewed patients that had labs ran on the machine and found this patient potentially had a false negative reading on her blood hcg on (b)(6). The patient returned on (b)(6) and had a positive hcg screening. The machine has been pulled from service and will be evaluated by roche.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067652 |
| MDR Report Key | 6300658 |
| Date Received | 2017-02-01 |
| Date of Report | 2017-02-01 |
| Date of Event | 2017-01-08 |
| Date Added to Maude | 2017-02-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROCHE COBAS |
| Generic Name | COBAS E411 |
| Product Code | CGN |
| Date Received | 2017-02-01 |
| Model Number | COBAS E411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE |
| Manufacturer Address | MANNHEIM DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-01 |