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 2016-02-17 for FREE PSA manufactured by Roche Diagnostics.
[38345931]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[38345932]
The customer reported that they received questionable results for a total of 50 patient samples tested for total prostate-specific antigen (tpsa) and free prostate-specific antigen (fpsa) tested on an e601 analyzer. Data was provided for a total of three patient samples and of these three samples, two had erroneous results for tpsa and fpsa. The fpsa results were higher than the tpsa results. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. The units of measure used for the tpsa and fpsa assays were asked for, but not provided. This medwatch will cover fpsa. Please refer to the medwatch with patient identifier (b)(6) for information related to tpsa. The first sample resulted as 0. 118 for fpsa and 0. 005 for tpsa on (b)(6) 2015. The second sample resulted as 0. 118 for fpsa and 0. 010 for tpsa on (b)(6) 2015. The patients were not adversely affected. The e601 analyzer serial number was (b)(4). A specific root cause could not be determined based on the provided information. The patient samples were requested for investigation, but could not be provided.
Patient Sequence No: 1, Text Type: D, B5
[39108862]
The units of measure used for the tpsa and fpsa assays are ng/ml.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00172 |
| MDR Report Key | 5441201 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-17 |
| Date of Report | 2016-02-26 |
| Date of Event | 2015-12-15 |
| Date Mfgr Received | 2016-01-26 |
| Date Added to Maude | 2016-02-17 |
| 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 | FREE PSA |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2016-02-17 |
| 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 | 2016-02-17 |