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 2018-12-19 for TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) 04641655190 manufactured by Roche Diagnostics.
[131144264]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[131144285]
The customer complained of questionable elecsys free psa immunoassay (freepsa) and elecsys total psa immunoassay (tpsa) results for 1 patient tested on a cobas e 411 immunoassay analyzer. The customer tested two separate samples (sample a and sample b) from the same patient. This medwatch will cover tpsa. Please refer to the medwatch with patient identifier (b)(6) for information on the freepsa. For sample a: the initial tpsa result was 0. 154 ng/ml with a repeat result of 0. 163 ng/ml. The initial freepsa result was 4. 91 ng/ml with a repeat result of 4. 89 ng/ml. For sample b: on (b)(6) 2018 the initial tpsa result was 0. 207 ng/ml. The same patient sample was tested on a cobas 8000 and a tpsa result of 0. 158 ng/ml was obtained. On (b)(6) 2018 the initial freepsa result was 5. 05 ng/ml. The same patient sample was tested on a cobas 8000 and a freepsa result of 4. 43 ng/ml was obtained. The erroneous results were not reported outside of the laboratory. There was no allegation of an adverse event. The cobas e411 serial number was (b)(4). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04982 |
| MDR Report Key | 8178448 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2018-12-19 |
| 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 | 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 | 2018-12-19 |
| Model Number | NA |
| Catalog Number | 04641655190 |
| Lot Number | 31571405 |
| 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 | 2018-12-19 |