MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-08 for ELECSYS FREE PSA IMMUNOASSAY 03289788160 manufactured by Roche Diagnostics.
[97729193]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[97729194]
The customer stated that they received erroneous results for two patient samples tested for the elecsys total psa immunoassay (tpsa) and the elecsys free psa immunoassay (fpsa) on a cobas e 411 immunoassay analyzer (e411). The fpsa results were higher than the tpsa results for these samples. The date of the event was asked for, but not known. The first sample was tested sometime in (b)(6) 2017. This medwatch will apply to the fpsa assay. Please refer to the medwatch with (b)(6) for information related to the tpsa assay. The customer was asked, but unable to provide any data from the first patient sample. This sample had a fpsa result that was higher than the tpsa result. This sample was tested sometime in (b)(6) 2017, but the customer did not provide a specific date that this sample was tested. The sample was repeated before results were released outside of the laboratory. The second patient sample, from a (b)(6) male patient (b)(6), had a fpsa result of 2. 45 ng/ml and a tpsa result of 1. 55 ng/ml on (b)(6) 2017. No adverse events were alleged to have occurred with the patients. The e411 analyzer serial number was (b)(4). The field service engineer checked the analyzer maintenance log and operation of the system. He ran performance testing and all results were within range. The analyzer was found to be operating within specifications.
Patient Sequence No: 1, Text Type: D, B5
[131700399]
Upon review of calibration data, calibration signals were lower than expected.
Patient Sequence No: 1, Text Type: N, H10
[131703719]
Quality control values from (b)(4) 2017 and (b)(4) 2017 were within specified ranges. The investigation was unable to find a definitive root cause. Based upon the provided information, an assay related issue could not be detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00083 |
| MDR Report Key | 7172632 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-08 |
| Date of Report | 2018-03-06 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-12-22 |
| Date Added to Maude | 2018-01-08 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 2018-01-08 |
| Model Number | NA |
| Catalog Number | 03289788160 |
| Lot Number | 243142 |
| 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 | 2018-01-08 |