MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-19 for COBAS E-ELECSYS ESTRADIOL GEN.2 03000079190 manufactured by Roche Diagnostics.
[3191014]
The customer received questionable estradiol results for three patient samples and a questionable progesterone result for one other patient sample from the cobas e601 analyzer serial number (b)(4). Of the data provided, the estradiol result for one patient sample was discrepant. The initial result was 866. 5 pg/ml and the repeat result was 599. 5 pg/ml all of the results were reported outside the laboratory. The repeat results were believed to be correct. The patients were not adversely affected. The customer stated they replaced the estradiol reagent pack which resolved the issue. The field service representative determined the reagent was old, expired or exposed to ambient temperature. He confirmed the reagent was replaced with a new lot and problem was no longer encountered.
Patient Sequence No: 1, Text Type: D, B5
[10541389]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-00990 |
| MDR Report Key | 2967936 |
| Report Source | 05,06 |
| Date Received | 2013-02-19 |
| Date of Report | 2013-02-19 |
| Date of Event | 2013-01-29 |
| Date Mfgr Received | 2013-01-30 |
| Date Added to Maude | 2013-02-19 |
| 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS E-ELECSYS ESTRADIOL GEN.2 |
| Generic Name | RADIOIMMUNOASSAY,ESTRADIOL |
| Product Code | JIS |
| Date Received | 2013-02-19 |
| Model Number | NA |
| Catalog Number | 03000079190 |
| Lot Number | 17033801 |
| ID Number | NA |
| Device Expiration Date | 2013-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-02-19 |