MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-08-27 for ELECSYS PROLACTIN ASSAY 07027737190 manufactured by Roche Diagnostics.
[118406749]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[118406770]
The customer stated that they received an erroneous result for one patient sample tested with the elecsys prolactin assay on a cobas 8000 e 801 module. It was asked, but it is not known if the erroneous result was reported outside of the laboratory. The customer routinely tests samples for prolactin on their tosoh aia-2000 analyzer. The sample was initially tested on the aia-2000 analyzer, resulting with a prolactin value of 255. 8 ng/ml. The physician questioned the result and asked for the sample to be repeated on the e 801 analyzer. The repeat prolactin result from the e 801 analyzer was 343. 9 ng/ml. No adverse events were alleged to have occurred with the patient. The serial number of the e 801 analyzer was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02871 |
| MDR Report Key | 7818081 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-27 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-08-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| 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 | ELECSYS PROLACTIN ASSAY |
| Generic Name | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
| Product Code | CFT |
| Date Received | 2018-08-27 |
| Model Number | NA |
| Catalog Number | 07027737190 |
| Lot Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-27 |