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 2011-10-04 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[2259153]
The customer received questionable igg antibodies to toxoplasma gondii (toxo igg) results on their e601 analyzer. The patient was being monitored monthly during her pregnancy for toxo igg using a vidas analyzer with negative results, <8 iu/ml. Prior to delivery, the patient's toxo igg results were 88 iu/ml and 86 iu/ml on the e601 analyzer. The patient's sample was sent to another laboratory for repeat testing as the patient had been testing negative for toxo igg. The sample was reported as negative using a vidas analyzer. The customer considers the results from the e601 to be false positive results. There were no allegations of adverse affects to the patient as a result of this event. The toxo igg reagent lot number was 161442 and the expiration date was 12/30/2011. No root cause has been determined. The investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
[9359815]
It was unknown if the initial reporter sent report to the fda. The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[16418770]
The patient had negative toxo igg results on a vidas analyzer for the previous eight months.
Patient Sequence No: 1, Text Type: N, H10
[18802524]
The patient sample was returned for investigation. Reactive/positive results were obtained. The positive toto igg result is regarded as correctly positive. The patient was not harmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-05212 |
| MDR Report Key | 2274644 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-04 |
| Date of Report | 2012-03-27 |
| Date of Event | 2011-09-06 |
| Date Mfgr Received | 2011-09-06 |
| Date Added to Maude | 2011-10-04 |
| 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 | 2011-10-04 |
| 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 | 2011-10-04 |