MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-04-18 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[42953785]
This event occurred in (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[42953786]
The customer reported that they received erroneous results for one patient sample tested for total prostate-specific antigen (tpsa) and free prostate-specific antigen (fpsa) on an e601 analyzer. The fpsa result was greater than the tpsa result. This medwatch will cover fpsa. Please refer to the medwatch with patient identifier (b)(6) for information related to tpsa. The sample resulted as 0. 149 ng/ml for tpsa and 2. 59 ng/ml for fpsa. The results were reported outside of the laboratory to the patient. The patient was not adversely affected. The e601 analyzer serial number was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[44897592]
A sample from the patient was provided for investigation. Investigations were able to confirm the customer's results. Investigations performed with an antibody that has a different specificity than the one used in the tpsa assay increased tpsa recovery of the sample significantly. Further investigations could not be performed since there was not enough sample remaining.
Patient Sequence No: 1, Text Type: N, H10
[47225049]
A new sample from the same patient has been provided for investigation. This sample also had erroneous results for fpsa and tpsa. This sample had a fpsa result of 3. 180 ng/ml and a tpsa result of 0. 220 ng/ml. The erroneous results were not reported outside of the laboratory. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: N, H10
[48207300]
Investigations of the new patient sample were able to confirm the customer's results. For investigations, a total psa reagent with different analyte specificity was used. Upon use of this reagent, a significant increase in total psa recovery of the sample can be seen. The result of total psa with this reagent is higher than the free psa result. The observed behavior may be explained by the presence of auto-antibodies blocking the epitope on complexed psa or an anti-idiotype antibody which blocks the catcher antibody of the total psa assay. Product labeling indicates that psa isoforms do exist which may be measured differently by different psa tests.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00446 |
| MDR Report Key | 5584535 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-18 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-03-31 |
| Date Added to Maude | 2016-04-18 |
| 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) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2016-04-18 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 188436 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-18 |