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 2019-03-18 for TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) 04641655190 manufactured by Roche Diagnostics.
[139087456]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[139087497]
The initial reporter questioned low results for multiple patients tested for elecsys total psa immunoassay (total psa) on a cobas e 411 immunoassay analyzer. The customer provided an example for 1 patient with an initial result from the e411 analyzer of 0. 002 ng/ml with a data flag. The sample was repeated twice at a different laboratory using the cobas 6000 e 601 module with results of 0. 158 ng/ml and 0. 157 ng/ml. The repeat results were believed to be correct based on the previous results for this patient and that the patient had a recent prostate carcinoma operation. The 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 pulled patient samples from the last 8 weeks (50 samples) and repeated them. Discrepant results were identified for all 50 samples. Refer to attached data for these results. The customer believes the issue was caused by a calibration issue from (b)(6) 2019. A field service engineer (fse) visited the customer site and performed new calibration and the customer has had no further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01109 |
| MDR Report Key | 8428346 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-18 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-03-18 |
| 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 FOR DETECTION OF PROSTATE CANCER |
| Product Code | MTF |
| Date Received | 2019-03-18 |
| Model Number | NA |
| Catalog Number | 04641655190 |
| Lot Number | 35107401 |
| 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 | 2019-03-18 |