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 2018-10-25 for ELECSYS TOTAL PSA IMMUNOASSAY 04491734190 manufactured by Roche Diagnostics.
[126240129]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[126240130]
The customer complained of a possible interference for 1 patient when tested for elecsys free psa immunoassay on a cobas 6000 e 601 module compared to the patient's elecsys total psa immunoassay results. The customer provided three separate incidents where the patient's free psa values were higher than their total psa results. This medwatch will cover the total psa data. Please refer to the medwatch with patient identifier (b)(6) for data on the free psa. On (b)(6) 2018 the free psa result was 0. 78 ng/ml with a total psa result of 0. 11 ng/ml. On (b)(6) 2018 the free psa result was 0. 61 ng/ml with a total psa result of 0. 12 ng/ml. On (b)(6) 2018 the free psa result was 0. 51 ng/ml with a total psa result of 0. 13 ng/ml. It was only provided that the results from (b)(6) 2018 were released outside of the laboratory. There was no allegation of any adverse events. The only free psa and total psa reagent lot information provided was for the results obtained on (b)(6) 2018. The cobas e602 used for the (b)(6) 2018 results was (b)(4). The investigation showed that the calibration and qc data that was provided was acceptable. On the day of the (b)(6) 2018 measurements, there was no qc testing performed. The customer provided the patient sample from (b)(6) 2018 for further investigation. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03823 |
| MDR Report Key | 8004054 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-25 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-10-05 |
| Date Added to Maude | 2018-10-25 |
| 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 | ELECSYS TOTAL PSA IMMUNOASSAY |
| Generic Name | TOTAL,PROSTATE SPECIFIC AG(NONCOMPLEXED&COMPLEXED) |
| Product Code | MTF |
| Date Received | 2018-10-25 |
| Model Number | NA |
| Catalog Number | 04491734190 |
| Lot Number | 311233 |
| Device Expiration Date | 2019-07-31 |
| 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 | 2018-10-25 |