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 2018-01-11 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[97857465]
(b)(6). (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[97857466]
The customer stated that they received erroneous results for one patient sample tested for elecsys total psa immunoassay (tpsa) and elecsys free psa immunoassay (fpsa) on a cobas 6000 e 601 module (e601). The patient was at the site for a follow up visit after having a prostatectomy. The sample resulted with a tpsa value of 0. 003 ng/ml accompanied by a data flag and a fpsa value of 0. 13 ng/ml. Both tests were repeated and the results could be duplicated. No specific data was provided. No erroneous results were reported outside of the laboratory. No adverse events were alleged to have occurred with the patient. The serial number of the e601 analyzer was asked for, but not provided. This medwatch will apply to the fpsa assay. Please refer to (b)(6) for information related to the tpsa assay.
Patient Sequence No: 1, Text Type: D, B5
[131712906]
The correct fpsa value of the sample was 0. 124 ng/ml. The sample also had the following additional test data on (b)(4) 2018: a-tg = < 10. 00 ui/ml, vitd-t = 16. 04 ng/ml. The serial number of the e601 analyzer was (b)(4).. A sample from the patient was provided for investigation. Investigations were unable to duplicate the fpsa value measured by the customer. The tpsa value was duplicated. There was no remaining volume of the sample available for further investigations. The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00129 |
| MDR Report Key | 7182014 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-11 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-01-02 |
| Date Mfgr Received | 2018-01-03 |
| Date Added to Maude | 2018-01-11 |
| 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 | FREE PSA |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2018-01-11 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 293436 |
| ID Number | NA |
| 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 | 2018-01-11 |