MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-02-26 for FREE PSA manufactured by Roche Diagnostics.
[18034443]
The customer received questionable total psa total (free + complexed) psa - prostate-specific antigen (total psa) and free psa results for an unknown number of patient samples. Of the data provided, only the data for one patient was discrepant and did not agree with the clinical status of the patient. (b)(4). The initial results for the patient from cobas e411 serial number (b)(4) were total psa: 94. 42 ng/ml and free psa: 15. 25 ng/ml. The urologist questioned these results and sent the sample to be tested at three other sites. Site 1 (modular e170) on (b)(6) 2015: total psa: 90. 19 ng/ml free psa: 22. 69 ng/ml. Site 2 (cobas e411) on (b)(6) 2015: total psa: 73. 99 ng/ml free psa: 13 ng/ml. Site 3 (cobas e411) on (b)(6) 2015: total psa: 67. 67 ng/ml free psa: 13. 77 ng/ml. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[18134187]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[18442893]
A specific root cause could not be identified as the sample was not available for further testing. Additional information for further investigation such as which result was believed to be correct was requested but was not provided. Review of the provided calibration and qc data did not indicate a general reagent or system issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-01576 |
| MDR Report Key | 4549117 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-26 |
| Date of Report | 2015-04-15 |
| Date of Event | 2015-02-06 |
| Date Mfgr Received | 2015-02-10 |
| Date Added to Maude | 2015-02-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 | 2015-02-26 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-26 |