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 2015-07-27 for FREE PSA 03289788160 manufactured by Roche Diagnostics.
[6037745]
The customer received questionable total psa total (free + complexed) psa - prostate-specific antigen (total psa) and free psa results for one patient sample. Refer to the medwatch with patient identifier (b)(6) for the total psa assay. The initial total psa result from the cobas 8000 analyzer was 0. 750 ng/ml. The repeat result from a cobas 6000 analyzer was 0. 753 ng/ml. The initial free psa result from cobas e411 serial number (b)(4) was 3. 43 ng/ml. The repeat result was 3. 44 ng/ml. The total psa result of 0. 750 ng/ml and free psa result of 3. 43 ng/ml were reported outside the laboratory. The patient was not adversely affected. As the sample was no longer available for investigation, a specific root cause could not be determined. A general reagent issue was not suspected.
Patient Sequence No: 1, Text Type: D, B5
[13712553]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03864 |
| MDR Report Key | 4943003 |
| Report Source | 01,05,06 |
| Date Received | 2015-07-27 |
| Date of Report | 2015-07-27 |
| Date of Event | 2015-07-09 |
| Date Mfgr Received | 2015-07-09 |
| Date Added to Maude | 2015-07-27 |
| 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 | 2015-07-27 |
| Model Number | NA |
| Catalog Number | 03289788160 |
| Lot Number | 178872 |
| 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 IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-27 |