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 2017-03-21 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK 04775201001 manufactured by Roche Diagnostics.
[70431327]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70431328]
The customer questioned results for 2 patients tested for elecsys cea assay(cea) and elecsys ca 19-9 immunoassay (ca 19-9) on a cobas e 411 immunoassay analyzer. The cea results for 1 patient were erroneous. It is not known if the erroneous results were reported outside of the laboratory. The initial cea result was 9. 7 ng/ml. The sample was repeated twice with results of 4. 0 ng/ml and 3. 98 ng/ml. The patient was also tested for tsh, ft4, afp and ca 19-9; however, those results were not questioned. The specific results for these other tests were not provided. There was no allegation that an adverse event occurred. The cea reagent lot number and expiration date were not provided.
Patient Sequence No: 1, Text Type: D, B5
[71603587]
The customer has not had any additional issues since the event for this 1 patient on (b)(6) 2017.
Patient Sequence No: 1, Text Type: N, H10
[73014425]
A specific root cause could not be identified. Additional information was requested for investigation but was not provided. The instrument is operating within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00596 |
| MDR Report Key | 6420403 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-21 |
| Date of Report | 2017-04-17 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-03-01 |
| Date Added to Maude | 2017-03-21 |
| 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 | DHX |
| Date Received | 2017-03-21 |
| Model Number | E411 RACK |
| Catalog Number | 04775201001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-03-21 |
| Model Number | E411 RACK |
| Catalog Number | 04775201001 |
| 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 | 2017-03-21 |