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 2017-03-03 for ELECSYS FREE PSA IMMUNOASSAY manufactured by Roche Diagnostics.
[69019284]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69019285]
The customer stated that they received erroneous results for one patient sample tested for the elecsys total psa immunoassay (tpsa) and the elecsys free psa immunoassay (fpsa) on a cobas 6000 e 601 module (e601). The fpsa value was higher than the tpsa value. It was asked, but it is not known if an erroneous result was reported outside of the laboratory. This medwatch will apply to the fpsa assay. Please refer to the medwatch with patient identifier (b)(6) for information related to the tpsa assay. The sample resulted as 0. 66 ng/ml when tested for tpsa and resulted as 0. 69 ng/ml when tested for fpsa. The sample was repeated for tpsa and the result was 0. 66 ng/ml. The patient was not adversely affected. The e601 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[71119419]
The patient sample was tested for tpsa using a "clia" test method and the result was 0. 69 ng/ml. The sample was provided for investigation, where it was tested on an e601 analyzer and an e602 analyzer. When tested on an e601 analyzer on (b)(6) 2017, the sample had a tpsa result of 0. 601 ng/ml and an fsa result of 0. 660 ng/ml. The sample was repeated on the e601 analyzer on (b)(6) 2017, resulting with a tpsa value of 0. 600 ng/ml and a fpsa value of 0. 649 ng/ml. When tested on the e602 analyzer on (b)(6) 2017, the sample had a tpsa result of 0. 614 ng/ml and a fpsa result of 0. 643 ng/ml. The sample was also tested using an outsourced "psa-act"/"acs-cpsa free psa" test method on the advia centaur analyzer, resulting with a value of 0. 2 ng/ml. Preliminary investigations determined the issue may be related to the very low psa concentration of the sample. A non-specific reaction was not observed. The serial numbers of the e601 analyzer and e602 analyzer used for investigations were asked for, but not provided. The reagent lot number used on the investigation e601 analyzer was fpsa reagent lot number 150990, with an expiration date of 08/31/2017. The reagent lot number used on the investigation e602 analyzer was fpsa reagent lot number 150990, with an expiration date of 08/31/2017.
Patient Sequence No: 1, Text Type: N, H10
[71849527]
A specific root cause could not be determined based on the provided information. The involved sample could not be made available for further investigations. The customer's observation was duplicated. A general product problem could be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00455 |
| MDR Report Key | 6375886 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-03 |
| Date of Report | 2017-04-05 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-02-09 |
| Date Added to Maude | 2017-03-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ELECSYS FREE PSA IMMUNOASSAY |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2017-03-03 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2017-03-03 |