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 2019-03-20 for ELECSYS TOTAL PSA IMMUNOASSAY 07027966190 manufactured by Roche Diagnostics.
[139697157]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[139697158]
The initial reporter complained of discrepant results for 1 patient tested for elecsys free psa (free psa) and elecsys total psa (total psa) on a cobas e 801 module. This medwatch will cover total psa. Refer to medwatch with patient identifier (b)(6) for information on the free psa results. The total psa result was 0. 421 ng/ml. The free psa result was 0. 672 ng/ml. The customer re-measured the patient sample and obtained the same results. The actual results were not provided. No erroneous results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The e801 module serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01141 |
| MDR Report Key | 8437078 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-20 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-20 |
| 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 TOTAL PSA IMMUNOASSAY |
| Generic Name | TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER |
| Product Code | MTF |
| Date Received | 2019-03-20 |
| Model Number | NA |
| Catalog Number | 07027966190 |
| Lot Number | 340180 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-20 |