MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-03-13 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[5696115]
The customer stated that they obtained erroneous results for two samples from one patient tested for total (free + complexed) psa - prostate-specific antigen (tpsa) and free psa (fpsa) on an e601 analyzer. The fpsa results of the patient were greater than the tpsa results. The erroneous results from one of the two patient samples were reported outside of the laboratory. This medwatch will cover the fpsa assay. (b)(4). The patient sample resulted as 2. 62 ng/ml for fpsa and 0. 62 ng/ml for tpsa. The patient was not adversely affected. The e601 analyzer serial number was (b)(4). A specific root cause could not be determined based on the information provided. A sample from the patient was requested for investigation purposes, but could not be provided.
Patient Sequence No: 1, Text Type: D, B5
[13010203]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-02027 |
| MDR Report Key | 4599978 |
| Report Source | 01,05,06 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-03-13 |
| Date of Event | 2014-08-19 |
| Date Mfgr Received | 2015-02-19 |
| Date Added to Maude | 2015-03-13 |
| 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 | 0 |
| 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 | 2015-03-13 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-13 |