MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-12-17 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[8819909]
Investigation of the patient sample verified the positive elecsys toxoplasma igg results. The positive results was further confirmed by neutralization assay as well as competitor assays, bouty beia toxoplasma igg assays (quant and avidity). The elcsys toxoplasma igg results are regarded as correctly reactive. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
[21680336]
The customer received questionable toxoplasma igg (igg antibodies to toxoplasma gondii) for one patient sample. The initial toxoplasma igg result was 121. 4 iu/ml. The physician ordered additional testing be performed. The sample was repeated using an unknown competitor assay, it generated a negative result. Avidity testing performed on the sample was also negative. The patient's toxoplasma igm results have always been negative. All results were reported outside the laboratory and to the physician. The patient was not harmed by the event. The toxoplasma igg reagent lot number was 00158276.
Patient Sequence No: 1, Text Type: D, B5
[21821531]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07535 |
| MDR Report Key | 1931053 |
| Report Source | 01,05,06 |
| Date Received | 2010-12-17 |
| Date of Report | 2011-01-04 |
| Date of Event | 2010-11-05 |
| Date Mfgr Received | 2010-12-01 |
| Date Added to Maude | 2011-04-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| 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 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 | GMN |
| Date Received | 2010-12-17 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| 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 | 2010-12-17 |