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 2015-11-10 for COBAS E411 RACK SYSTEM 04775201001 manufactured by Roche Diagnostics.
[30901129]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30901130]
The customer received questionable igg antibodies to cytomegalovirus (cmv igg) results for two samples from one patient. For a sample tested (b)(6) 2015, the result was 1. 19 u/ml (reactive). For a sample tested (b)(6) 2015, the result was 1. 16 u/ml (reactive). On (b)(6) 2015, the sample from (b)(6) 2015 was sent to anther laboratory and was tested on an abbott architect. The result was 0. 1 au/ml (negative). On (b)(6) 2015, both samples from the patient were repeated on the cobas e411 analyzer. The result for the (b)(6) 2015 sample was 1. 14 u/ml (reactive) and the result for the (b)(6) 2015 sample was 1. 18 u/ml (reactive). The results from the cobas e411 were reported outside of the laboratory. The patient was not adversely affected. The reagent lot number was 185518. The expiration date was requested, but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[33639166]
A specific root cause could not be identified. Sample from the patient was submitted for investigation, but the sample material was received frozen and unsuitable for testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04511 |
| MDR Report Key | 5214586 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-10 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-10-13 |
| Date Mfgr Received | 2015-10-23 |
| Date Added to Maude | 2015-11-10 |
| 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 E411 RACK SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LIN |
| Date Received | 2015-11-10 |
| Model Number | NA |
| 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 46250 US 46250 |
| Brand Name | COBAS E411 RACK SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-11-10 |
| Model Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-10 |