MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-06 for FREE PSA 03289788160 manufactured by Roche Diagnostics.
[5557153]
The customer received questionable total psa total (free + complexed) psa - prostate-specific antigen (total psa) and free psa results for one patient sample from the analytical e module serial number (b)(4). Refer to the medwatch with patient identifier (b)(6) for the total psa assay. The initial total psa result was 0. 047 ng/ml and was reported outside the laboratory as <0. 1 ng/ml. The free psa result was 2. 28 ng/ml and was reported outside the laboratory. These results were questioned by the physician as the total psa result was higher than the free psa result. Neither result was believed to be correct. The patient was not adversely affected. The field service representatives could not find a cause and could not replicate the issue. Assay performance checks and calibrations were performed. The customer ran qc and precision testing. All mechanical and fluidic checks passed guidelines. All qc was within limits and precision testing passed guidelines.
Patient Sequence No: 1, Text Type: D, B5
[13124978]
It was unknown if the initial reporter sent report to the fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[22229804]
A specific root cause could not be identified. Based on the provided calibration and qc data, a general issue with the reagent was not indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-01809 |
| MDR Report Key | 4576151 |
| Report Source | 05,06 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-02-07 |
| Date Mfgr Received | 2015-02-19 |
| Date Added to Maude | 2015-03-06 |
| 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 | 2015-03-06 |
| Model Number | NA |
| Catalog Number | 03289788160 |
| Lot Number | 18024301 |
| ID Number | NA |
| Device Expiration Date | 2015-10-31 |
| 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 | 2015-03-06 |