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 2017-10-23 for ELECSYS FREE PSA IMMUNOASSAY 03289788160 manufactured by Roche Diagnostics.
[90852072]
(b)(4). The event occurred in:(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[90852073]
The customer experienced an issue where the elecsys free psa immunoassay results were higher than the elecsys total psa immunoassay results for one patient. The customer used a cobas e 411 immunoassay analyzer with a serial number of (b)(4). The initial free psa result was 0. 426 ng/ml and the initial total psa result was 0. 165 ng/ml. The sample was repeated with a free psa result of 0. 427 ng/ml and a total psa result of 0. 151 ng/ml. An aliquot of the same sample was tested in another laboratory using the same elecsys test. The free psa result was 0. 440 ng/ml and a total psa result of 0. 12 ng/ml. The results were not reported outside of the laboratory. There was no allegation of an adverse event. Refer to the medwatch with a1 patient identifier (b)(6) for the total psa assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02401 |
| MDR Report Key | 6969211 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-23 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-10-03 |
| Date Mfgr Received | 2017-10-09 |
| Date Added to Maude | 2017-10-23 |
| 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 FREE PSA IMMUNOASSAY |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2017-10-23 |
| Model Number | NA |
| Catalog Number | 03289788160 |
| Lot Number | 20987702 |
| 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 | 2017-10-23 |