MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-12-20 for ELECSYS FREE PSA IMMUNOASSAY 03289788160 manufactured by Roche Diagnostics.
[95903516]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95903517]
The customer complained of questionable results for 1 patient sample tested for elecsys free psa immunoassay elecsys (psa free) total psa immunoassay (psa total) on a cobas 8000 e 602 module. (b)(4). The initial psa free result was 0. 3 ng/ml which was greater than the initial psa total result of 0. 06 ng/ml. There were no flags present on the initial results. The customer repeated the sample for both psa free and psa total on both the same analyzer and on another analyzer, running the sample both undiluted and diluted, and all the results obtained matched (no specific values provided). The erroneous results were reported outside of the laboratory. There was no adverse event. The customer stated that all qc results have been within range. The field engineering specialist was not able to find a cause. He checked the instrument and found no issues. He ran performance and precision testing which had acceptable results. Psa total qc testing was performed which passed. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-03058 |
| MDR Report Key | 7133310 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-20 |
| Date of Report | 2018-02-12 |
| Date of Event | 2017-12-09 |
| Date Mfgr Received | 2017-12-11 |
| Date Added to Maude | 2017-12-20 |
| 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 | 2017-12-20 |
| Model Number | NA |
| Catalog Number | 03289788160 |
| Lot Number | 24314201 |
| ID Number | NA |
| Device Expiration Date | 2018-09-30 |
| 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 | 2017-12-20 |