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 2018-08-17 for ELECSYS TOTAL PSA IMMUNOASSAY manufactured by Roche Diagnostics.
[117707345]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[117707346]
The customer complained of questionable elecsys free psa immunoassay and elecsys total psa immunoassay results for 1 patient sample tested on a cobas 8000 e801 module. The customer suspects that there is an interference present in the patient sample. This medwatch will cover the total psa data. Please refer to the medwatch with patient identifier (b)(6) for data on the free psa. The initial free psa result was 3. 87 ng/ml with repeat results of 3. 91 ng/ml and 3. 65 ng/ml. The initial total psa result was 3. 00 ng/ml with repeat results of 3. 05 ng/ml and 2. 99 ng/ml. No erroneous results were released outside of the laboratory. There was no allegation of an adverse event. The cobas e801 serial number was (b)(4). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02751 |
| MDR Report Key | 7792763 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-17 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-01 |
| Date Added to Maude | 2018-08-17 |
| 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 | 2018-08-17 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 315740 |
| 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 | 2018-08-17 |