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.
[2259154]
The customer received questionable igg antibodies to rubella virus (rubella igg) results on their e601. The patient was being monitored throughout her pregnancy for rubella igg on a vidas analyzer with negative results. Prior to delivery on (b)(6) 2011, the patient had a sample tested with a positive rubella igg result of 45. 94 iu/ml on the customer's e601 analyzer. The sample was sent to a different laboratory and was tested on a vida analyzer with a negative result of <10 iu/ml. The customer tested a sample from (b)(6) 2011 which was negative for rubella igg on a vidas analyzer and the result from their e601 was 49. 83 iu/ml. The customer tested a sample from (b)(6) 2011 which was negative for rubella igg on a vidas analyzer and the result from their e601 was 41. 62 iu/ml. The customer considered the results from the e601 analyzer to be false positive results. There were no allegations of adverse affects to the patient from this event. The rubella igg reagent lot number was 160901 and the expiration date is 11/29/2011. No root cause has been determined. The investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
[9359816]
This event occured in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9386063]
New information was provided indicating the date of event, was (b)(6) 2011.
Patient Sequence No: 1, Text Type: N, H10
[9844193]
A patient sample was returned for investigation. The positive result for rubella igg was confirmed. This is supported by a positive blot result (recomblot). The elecsys rubella igg result is regarded as correctly positive. Discrepant results may be received when comparing results of different anti-rubella igg assays.
Patient Sequence No: 1, Text Type: N, H10
[18740577]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-05213 |
| MDR Report Key | 2274646 |
| 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 | DEW |
| 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 |