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 2018-05-10 for TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) manufactured by Roche Diagnostics.
[108249969]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[108249970]
The customer experienced an issue where the elecsys free psa immunoassay results were higher than the elecsys total psa immunoassay results for two samples from one patient. The customer used the cobas e 411 immunoassay analyzer serial number (b)(4). For the initial sample, the free psa result was 5. 56 ng/ml and the total psa result was 0. 25 ng/ml. The initial sample was repeated. The free psa result was 5. 77 ng/ml and the total psa result was 0. 23 ng/ml. The initial sample was repeated with an automatic 1:2 dilution. The free psa result was 5. 78 ng/ml and the total psa result was 0. 27 ng/ml. For the initial sample tested with the abbott method, the free psa result was 0. 08 ng/ml and the total psa result was 0. 56 ng/ml. On (b)(6) 2018 a new sample was collected from the patient. The free psa result was 5. 43 ng/ml and the total psa result was 0. 24 ng/ml. No erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. This medwatch will cover the total psa results. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01445 |
| MDR Report Key | 7503473 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-10 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2018-04-24 |
| Date Added to Maude | 2018-05-10 |
| 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 | TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) |
| Generic Name | TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS |
| Product Code | MTF |
| Date Received | 2018-05-10 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2018-05-10 |