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 2018-04-05 for ELECSYS TOTAL PSA IMMUNOASSAY 04491734160 manufactured by Roche Diagnostics.
[104840938]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[104840939]
The customer received questionable elecsys total psa immunoassay results for one patient compared to a siemens vista analyzer. Refer to the attachment to the medwatch for all patient data. The total psa was reported as <0. 1 ng/ml. The customer was not aware that the patient was treated based on the results and he did not know if the patient had his prostate removed. There was no allegation of an adverse event. The customer performed a biotin study which showed no interference. The sample had no change in results when treated with streptavidin. The customer declined a service visit as they did not believe there was an analyzer issue. He stated the cobas e601 results were probably correct as they were supported by a similar result from the beckman analyzer. The customer used cobas 6000 e 601 module serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01059 |
| MDR Report Key | 7398697 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-05 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-04-05 |
| 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 | ELECSYS TOTAL PSA IMMUNOASSAY |
| Generic Name | TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS |
| Product Code | MTF |
| Date Received | 2018-04-05 |
| Model Number | NA |
| Catalog Number | 04491734160 |
| Lot Number | 21602701 |
| ID Number | NA |
| Device Expiration Date | 2018-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-05 |