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 2016-06-27 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[48307933]
This event occurred in (b)(6). (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[48307934]
The customer stated that they received erroneous results for one patient sample tested for total prostate-specific antigen (tpsa) and free prostate-specific antigen (fpsa). The fpsa results were higher than the tpsa results. This medwatch will refer to fpsa. Please refer to the medwatch with patient identifier (b)(6) for information related to tpsa. A prior event for the same patient was previously reported in manufacturer report number 1823260-2015-03864. The sample initially resulted as 0. 937 ng/ml when tested for tpsa on an e601 analyzer and it resulted as 6. 44 ng/ml when tested for fpsa on an e411 analyzer. The sample was repeated on (b)(6) 2016, resulting as 0. 920 ng/ml when tested for tpsa on an e601 analyzer and resulting as 6. 41 ng/ml when tested for fpsa on an e411 analyzer. The tpsa result of 0. 920 ng/ml and the fpsa result of 6. 44 ng/ml were reported outside of the laboratory. The patient was not adversely affected. The serial numbers of the used e601 and e411 analyzers were asked for, but not provided. A specific root cause could not be determined based on the provided information. The sample was requested for investigation, but there was not sufficient volume of the sample remaining for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-00818 |
| MDR Report Key | 5751067 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-27 |
| Date of Report | 2016-06-27 |
| Date of Event | 2016-06-08 |
| Date Mfgr Received | 2016-06-09 |
| Date Added to Maude | 2016-06-27 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 2016-06-27 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 18843601 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| 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 | 2016-06-27 |