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 2011-08-08 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[1994228]
The customer received questionable results for one patient sample. The discrepant results led to an unclear toxoplasma igg status for the patient. The toxoplasma igg reagent (igg antibodies to toxoplasma gondii) lot number was 161442. The roche elecsys result was 301. 50 iu/ml. The confirmatory test result (using a liason instrument) was <3. 0 iu/ml. It is unknown which results were reported outside the laboratory. No adverse evnets have been alleged regarding the discrepancies.
Patient Sequence No: 1, Text Type: D, B5
[9216125]
It is unknown if the initial reporter sent a report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9403185]
New information was added.
Patient Sequence No: 1, Text Type: N, H10
[9460736]
The investigation could not determine a specific root cause. One sample was provided for investigation and the positive toxoplasma igg result obtained by the customer could not be verified. This sample tested negative for toxoplasma igg as well as toxoplasma igm and was consistent with the results obtained from the competitor assay. The customer confirmed the investigation results and no further investigation was done. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-04278 |
| MDR Report Key | 2195680 |
| Report Source | 01,05,06 |
| Date Received | 2011-08-08 |
| Date of Report | 2011-09-14 |
| Date of Event | 2011-07-10 |
| Date Mfgr Received | 2011-07-10 |
| Date Added to Maude | 2011-08-08 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 | LJK |
| Date Received | 2011-08-08 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| Lot Number | 2119-04 |
| 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 | 2011-08-08 |