MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-07-23 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[6011329]
The customer complained of erroneous results for 1 patient sample tested for free psa (free psa). The results were reported outside of the laboratory. The initial free psa result was 3. 79 ng/ml. The total (free + complexed) psa - prostate-specific antigen (tpsa) - (total psa) result was 0. 543 ng/ml. The sample was repeated and the free psa result was 3. 83 ng/ml. The total psa result was 0. 556 ng/ml. On (b)(6) 2015 the sample was tested on a different e601 analyzer and the free psa result was 3. 86 ng/ml. The total psa result was 0. 674 ng/ml. The sample was also tested on an architect analyzer where the free psa result was 0. 624 ng/ml. The total psa result was 1. 079 ng/ml. No adverse event occurred. The cobas e601 analyzer serial numbers were not provided.
Patient Sequence No: 1, Text Type: D, B5
[14378602]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[24989392]
A specific root cause could not be identified. The patient sample could not be provided for investigation. Based on the available data, there is no indication of an issue with the system or the reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03858 |
| MDR Report Key | 4936613 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-07-23 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-07-03 |
| Date Mfgr Received | 2015-07-06 |
| Date Added to Maude | 2015-07-23 |
| 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 | 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) |
| Product Code | MTG |
| Date Received | 2015-07-23 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 183535 |
| ID Number | NA |
| Device Expiration Date | 2016-05-30 |
| 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 | 2015-07-23 |