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 2010-12-07 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[1653144]
The user received questionable toxoplasma igg (igg antibodies to toxoplasma gondii) results for one patient sample. A woman who was known to be toxoplasma igg negative three months ago was retested on (b)(6) 2010. The first result received was 54. 59 iu/ml (positive) and the repeat result was 54. 40 iu/ml (positive). To clarify the positive result, the same sample was tested on a vidas analyzer and found negative. No specific data was provided for this result. The field service representative noticed that the serum was hemolytic and recentrifuged the sample. He then measured it in a sample cup with a positive result. No specific data was provided for this result. A second tube from this patient drawn two hours after the first sample was tested and the result was negative at 0. 130 iu/ml. None of the results were reported outside the laboratory. No adverse events were alleged regarding the issue. The toxoplasma igg reagent lot number was 158276. The user stated they believe the erroneous result was due to contamination of the sample.
Patient Sequence No: 1, Text Type: D, B5
[8802992]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[8874352]
The patient sample was not available for investigation. A root cause could not be identified. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07189 |
| MDR Report Key | 1916368 |
| Report Source | 01,05,06 |
| Date Received | 2010-12-07 |
| Date of Report | 2011-01-07 |
| Date of Event | 2010-11-22 |
| Date Mfgr Received | 2010-11-22 |
| 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 | 2010-12-07 |
| 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 | 2010-12-07 |