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 2017-11-07 for ELECSYS FREE PSA IMMUNOASSAY manufactured by Roche Diagnostics.
[92201029]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[92201030]
The customer complained of erroneous results for 1 patient tested for elecsys total psa immunoassay (total psa) and free psa on a cobas e 411 immunoassay analyzer. The erroneous results were not reported outside of the laboratory. This medwatch will cover free psa. Refer to medwatch with (b)(6) for information on the total psa erroneous results. (b)(6). There was no allegation that an adverse event occurred. The e411 analyzer serial number was not provided. Liquid flow cleaning was last performed on 28-sep-2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02550 |
| MDR Report Key | 7006653 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-07 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-17 |
| Date Added to Maude | 2017-11-07 |
| 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 FREE PSA IMMUNOASSAY |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2017-11-07 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 209877 |
| 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 | 2017-11-07 |