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 2019-01-02 for TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) 04641655190 manufactured by Roche Diagnostics.
[131786756]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[131786757]
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 e 411 immunoassay analyzer. This medwatch will cover total psa. Refer to medwatch with patient identifier (b)(6) for information on the free psa results. The initial total psa result was 0. 32 ng/ml. The initial free psa result was 0. 444 ng/ml. The repeat total psa result was 0. 297 ng/ml. The repeat free psa result was 0. 430 ng/ml. All results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The e411 analyzer serial number was (b)(4). The customer suspects an interfering factor affecting the results for this patient. The sample was requested for investigation but could not be provided. Based on the information provided, the investigation did not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00002 |
| MDR Report Key | 8208105 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-02 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-12-18 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2019-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 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 | 2019-01-02 |
| Model Number | NA |
| Catalog Number | 04641655190 |
| Lot Number | 315714 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-01-02 |