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 2017-07-07 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[79526321]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79526322]
The customer stated that they received erroneous results for one patient sample tested for the elecsys free psa immunoassay (fpsa) and the elecsys total psa immunoassay (tpsa) on a cobas 8000 e 602 module (e602). The fpsa result was higher than the tpsa result. The same results occur when other blood samples of the patient are tested (the fpsa result is greater than the tpsa result). This medwatch will apply to the fpsa assay. Patient identifier (b)(6) for information related to the tpsa assay. The sample resulted as 4. 78 ng/ml for fpsa and 0. 327 ng/ml for tpsa. No adverse events were alleged to have occurred with the patient. The e602 analyzer serial number was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[120550043]
The patient sample was provided for investigation. The customer's results were confirmed during the investigation. The sample contained an interferent to the tpsa assay. This limitation is covered in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01402 |
| MDR Report Key | 6692359 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-07 |
| Date of Report | 2017-07-24 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-07 |
| 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 | 2017-07-07 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 20987700 |
| 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 | 2017-07-07 |