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 2018-03-12 for TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) 04641655190 manufactured by Roche Diagnostics.
[102336450]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102336451]
The customer complained of discrepant results for 1 patient sample tested for elecsys total psa immunoassay (total psa) and elecsys free psa immunoassay (free psa) on a cobas 6000 e 601 module. This medwatch will cover total psa. Refer to medwatch with patient identifier (b)(6) for information on the free psa erroneous results. The initial total psa result from the e601 module was 0. 583 ng/ml. The sample was repeated on a different e601 module and the result was 0. 584 ng/ml. The initial free psa result from the e601 module was 1. 44 ng/ml. The sample was repeated on a different e601 module and the result was 1. 46 ng/ml. The same sample was repeated by an unspecified chemiluminescence method and the total psa result was 6. 71 ng/ml. No incorrect results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The e601 module serial number used for the initial results was (b)(4). The serial number for the e601 module used for repeat testing was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00773 |
| MDR Report Key | 7331228 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-12 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2018-02-22 |
| Date Added to Maude | 2018-03-12 |
| 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 | TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) |
| Generic Name | TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS |
| Product Code | MTF |
| Date Received | 2018-03-12 |
| Model Number | NA |
| Catalog Number | 04641655190 |
| Lot Number | 247045 |
| ID Number | NA |
| Device Expiration Date | 2018-09-30 |
| 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 | 2018-03-12 |