MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-02-19 for ELECSYS TOTAL PSA IMMUNOASSAY 07027966190 manufactured by Roche Diagnostics.
[136529751]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[136529752]
The customer received questionable high elecsys free psa immunoassay results for one patient from cobas e 801 module serial number (b)(4). The free psa results were 15. 1 and 15. 3 ug/l while the total psa result was 11. 6 ug/l. With a 1:2 dilution, the total psa result was 11. 5 ug/l. It was not known if any erroneous result was reported outside of the laboratory. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00680 |
| MDR Report Key | 8350033 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-19 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-02-04 |
| Date Added to Maude | 2019-02-19 |
| 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 | 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 TOTAL PSA IMMUNOASSAY |
| Generic Name | TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER |
| Product Code | MTF |
| Date Received | 2019-02-19 |
| Model Number | NA |
| Catalog Number | 07027966190 |
| Lot Number | 340180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-19 |