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 2015-04-27 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[5706226]
The customer received questionable free psa and total psa total (free + complexed) psa - prostate-specific antigen (total psa) results for one patient sample from cobas e601 analyzer serial number (b)(4). The specific date of testing was not provided. Refer to the medwatch with patient identifier (b)(6) for the total psa assay. The initial results were free psa 8. 72 ng/ml and total psa 0. 82 ng/ml. The repeat results were free psa 8. 72 ng/ml and total psa 0. 815 ng/ml. On 04/15/2015, the service personnel ran the sample a third time and the results were free psa 9. 31 ng/ml and total psa 0. 80 ng/ml. As the customer had another similar case, the customer sent the sample to be tested on an abbott and siemens centaur analyzer. Both of the results were a total psa greater than the free psa result. No specific data was provided. The laboratory's results and the results from the centaur were reported to their customer. Information concerning if the patient was adversely affected was requested, but was not provided. No action was taken based on the customer's results. As the sample could not be provided for further investigation, a specific root cause could not be determined. As the results for both assays were reproducible, interference in the sample was possible. Based on the provided calibration and qc data, a general reagent or system issue was not indicated.
Patient Sequence No: 1, Text Type: D, B5
[13154475]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03308 |
| MDR Report Key | 4731513 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-27 |
| Date of Report | 2015-04-27 |
| Date of Event | 2015-04-15 |
| Date Mfgr Received | 2015-04-16 |
| Date Added to Maude | 2015-04-27 |
| 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 | 2015-04-27 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 178872 |
| ID Number | NA |
| Device Expiration Date | 2015-10-30 |
| 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 | 2015-04-27 |