MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-01-10 for COBAS E 411 IMMUNOASSAY ANALYZER E411 DISK 4775279001 manufactured by Roche Diagnostics.
[97737260]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[97737261]
The customer received a discrepant (b)(6) elecsys anti-hcv ii immunoassay result for a patient sample on the cobas e 411 immunoassay analyzer. The initial result was (b)(6) and was reported outside of the laboratory. The customer repeated the sample because the patient had an (b)(6) result of (b)(6) on (b)(6) 2017. The repeat result was (b)(6). The calibration and quality control were acceptable. There was no allegation of an adverse event. The (b)(6) reagent lot number was 26719301. The expiration date was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[131710866]
The patient was born in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131710969]
The sample was investigated and determined to be positive. The customer's initial negative result could not be reproduced. The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00113 |
| MDR Report Key | 7179734 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-10 |
| Date of Report | 2018-03-19 |
| Date of Event | 2017-12-24 |
| Date Mfgr Received | 2017-12-27 |
| Date Added to Maude | 2018-01-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | MZP |
| Date Received | 2018-01-10 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2018-01-10 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-10 |