MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-15 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[28707536]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[28707537]
The customer complained about erroneous results for 1 patient tested for free psa (free psa) and total (free + complexed) psa - prostate-specific antigen (tpsa) (total psa). The erroneous results were reported outside of the laboratory. This medwatch will cover free psa. Refer to medwatch with (b)(6) for information on the total psa erroneous results. The initial total psa result was 0. 137 ng/ml. The initial free psa result was 2. 32 ng/ml. These results were reported outside of the laboratory where the doctor questioned them. The sample was repeated and the total psa result was 0. 134 ng/ml. The repeat free psa result was 2. 33 ng/ml. The sample was repeated again on (b)(6) 2015 and the total psa result was 0. 141 ng/ml and the free psa result was 2. 34 ng/ml. A new sample was obtained on (b)(6) 2015 and the initial total psa result was 0. 131 ng/ml. The initial free psa result was 2. 12 ng/ml. This sample was sent to another laboratory where a siemens instrument was used. The total psa result from the siemens instrument was 1. 68 ng/ml. The free psa result from the siemens instrument was 0. 04 ng/ml. These results were believed to be correct and more compatible with the patient condition. No adverse event occurred. The modular analytics e module serial number was (b)(4). Calibration and quality controls were acceptable. It was noted that the patient takes finasteride to treat baldness.
Patient Sequence No: 1, Text Type: D, B5
[38341517]
A patient sample was submitted for investigation. The customer's roche results were reproduced during the investigation. Based on the available information, there is an indication of an interference (the presence of auto-antibodies or an anti-idiotype antibody) in the sample causing the discrepant results. This interference is addressed in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04339 |
| MDR Report Key | 5151157 |
| Date Received | 2015-10-15 |
| Date of Report | 2016-02-17 |
| Date of Event | 2015-09-17 |
| Date Mfgr Received | 2015-09-28 |
| Date Added to Maude | 2015-10-15 |
| 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 | 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 | 2015-10-15 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 183535 |
| ID Number | NA |
| Device Expiration Date | 2016-05-31 |
| 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 | 2015-10-15 |