MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-05 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[1883793]
The user received a questionable free psa generation 2 result for one patient sample. The initial result was 4. 010 ng/ml and was reported outside the laboratory. The repeat result on the cobas e601 analyzer serial number (b)(4) was 0. 399 ng/ml. The user stated the initial result was not acted upon. No adverse events were alleged regarding the event. The free psa reagent lot number was 15810704. The field service representative could not find a cause. He inspected the valves for a malfunction and could find no problems with the system. To verify the analyzer operation, he ran performance testing with all results within specifications.
Patient Sequence No: 1, Text Type: D, B5
[9187805]
A specific root cause could not be identified. No adverse effects were alleged regarding the event.
Patient Sequence No: 1, Text Type: N, H10
[9226865]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-01868 |
| MDR Report Key | 2038504 |
| Report Source | 05,06 |
| Date Received | 2011-04-05 |
| Date of Report | 2011-05-05 |
| Date of Event | 2011-03-16 |
| Date Mfgr Received | 2011-03-16 |
| Date Added to Maude | 2011-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| 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 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NAF |
| Date Received | 2011-04-05 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2011-04-05 |