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 2018-02-15 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK 04775201001 manufactured by Roche Diagnostics.
[100451245]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[100451246]
The customer experienced an issue over several days where the elecsys free psa immunoassay would be ordered in the cobas e 411 immunoassay analyzer software for patient samples and qc material where the test had not been requested and the result for free psa was identical for all patient samples. The field service representative could not find a cause. Operational and mechanical checks were acceptable. The customer powered down and rebooted the analyzer multiple times. The customer's laboratory information system (lis) was also restarted. The instrument was then running as expected and the problem seemed to be resolved. On (b)(6) 2018, the customer repeated all of the patient samples. Two examples were provided. Patient 1 original result was 39. 98 ng/ml and the repeat result was 1. 87 ng/ml. Patient 2 original result was 39. 98 ng/ml and the repeat result was 0. 488 ng/ml. No erroneous results were reported outside of the laboratory. The repeat results were believed to be correct. No patients were adversely affected. The free psa reagent lot number was 243142. The expiration date was requested but was not provided. The investigation confirmed the software issue which has been corrected in a new software version.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00453 |
| MDR Report Key | 7273535 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-15 |
| Date of Report | 2018-02-15 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2018-02-15 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | LTJ |
| Date Received | 2018-02-15 |
| Model Number | E411 RACK |
| Catalog Number | 04775201001 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-15 |