MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-06-30 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[1676434]
This x-ray system would not allow the visual sub unit (vilsub) to be setup.
Patient Sequence No: 1, Text Type: D, B5
[8903814]
A specific root cause could not be identified. The discrepant results in comparison to the competitor assays may be due to different epitope recognition used in the assay from different manufacturers. This can lead to different detection. As no sample was provided for investigation, interference analysis was not possible. No instrument or reagent related issue could be identified in the provided data. The customer could not provide any information regarding the patient's status or history. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: N, H10
[16660407]
.
Patient Sequence No: 1, Text Type: N, H10
[16702440]
The field application specialist reported the user received questionable total psa results for one patient sample. The initial result from the cobas e601 analyzer was 4. 08 ng/ml and the repeat result was 4. 12 ng/ml. The sample was repeated on a centaur analyzer with an initial result of 0. 31 ng/ml and a repeat result of 0. 20 ng/ml. The results 4. 08 and 0. 31 ng/ml were reported outside of the laboratory. The patient was not affected by the event. On (b)(6) 2010, the user performed a 1:5 dilution of the sample with a "treatment of heterophilic blocking tube" and received a result of 4. 59 ng/ml. The sample was tested again undiluted with the heterophilic blocking tube and generated a result of 4. 03 ng/ml on the e601 analyzer and 0. 19 ng/ml on the centaur analyzer. On (b)(6) 2010, the sample was sent to a reference lab and tested on a beckman analyzer. The result was 0. 14 ng/ml. The total psa reagent lot number was 15719901. The user stated this was the only sample affected and they do not believe the event was instrument related. The user refused a service visit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2010-03968 |
| MDR Report Key | 1742744 |
| Report Source | * |
| Date Received | 2010-06-30 |
| Date of Report | 2010-12-02 |
| Date of Event | 2010-05-27 |
| Date Mfgr Received | 2010-06-08 |
| Date Added to Maude | 2010-12-02 |
| 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 | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NAF |
| Date Received | 2010-06-30 |
| Catalog Number | 04745922001 |
| 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 INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-30 |