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 2017-09-15 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[86414191]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[86414194]
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 cobas e 411 (disk) immunoassay analyzer (b)(4). The free psa result was 3. 36 ng/ml and the total psa result was 0. 319 ng/ml. The sample was tested in another laboratory by clia. The free psa result was 0. 17 ng/ml and the total psa result was 1. 17 ng/ml. A second sample was taken from the patient on (b)(6) 2017. The free psa result was 3. 81 ng/ml and the total psa result was 0. 313 ng/ml. The second sample was tested in another laboratory on another cobas e 411 immunoassay analyzer. The serial number of this analyzer was not provided. The free psa result was 3. 40 ng/ml and the total psa result was 0. 33 ng/ml. The results were reported outside of the laboratory. There was no allegation of an adverse event. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01997 |
| MDR Report Key | 6867973 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-15 |
| Date of Report | 2017-12-17 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-27 |
| Date Added to Maude | 2017-09-15 |
| 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 | FREE PSA |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2017-09-15 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 20987702 |
| ID Number | NA |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-09-15 |