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 2015-05-13 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[5778201]
The customer received questionable total psa total (free + complexed) psa - prostate-specific antigen (total psa) and free psa results for one patient sample from cobas e601 analyzer serial number (b)(4). The specific date of testing was not provided. The initial free-psa result was 1. 64 ng/ml and the initial total psa result was 0. 902 ng/ml. The customer recentrifuged the sample and repeated testing with the same results. (b)(4). Information concerning if any erroneous result was reported outside the laboratory was requested, but was not provided. No adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
[13446374]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[13488582]
A specific root cause could not be identified as no patient sample could be provided for further investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03455 |
| MDR Report Key | 4768797 |
| Report Source | 01,05,06 |
| Date Received | 2015-05-13 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-04-30 |
| Date Mfgr Received | 2015-04-30 |
| Date Added to Maude | 2015-05-13 |
| 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 | 2015-05-13 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 178872 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-13 |