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 2018-11-19 for ELECSYS TOTAL PSA IMMUNOASSAY 04491734190 manufactured by Roche Diagnostics.
[129184000]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[129184001]
The customer received a questionable high elecsys total psa immunoassay result for one patient sample from cobas e 801 module 1617-07. The result did not fit with the clinical picture for the patient. The patient was being treated for prostate cancer and the previous total psa results had been low. Refer to the attachment to the medwatch for all patient data. On (b)(6) 2018, the total psa result was 2. 7 ng/ml. A few days later, a new sample was drawn from the patient and the total psa result was 0. 27 ng/ml. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04378 |
| MDR Report Key | 8085288 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-19 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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(NONCOMPLEXED&COMPLEXED) |
| Product Code | MTF |
| Date Received | 2018-11-19 |
| Model Number | NA |
| Catalog Number | 04491734190 |
| 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 | 2018-11-19 |