MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-04-29 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[44022346]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44022347]
The customer complained of erroneous results for 2 patients tested for total (free + complexed) psa - prostate-specific antigen (tpsa) - total psa and free psa (free psa). It is not known if erroneous result were reported outside of the laboratory. It is not known which results are believed to be correct. This information has been requested. This medwatch will cover free psa. Refer to medwatch with patient identifier (b)(6) for information on the total psa erroneous results. Patient 1: total psa result was 0. 002 ng/dl. The free psa result was 0. 015 ng/dl. Patient 2: total psa result was 0. 002 ng/dl. The free psa result was 0. 015 ng/dl. No adverse event occurred. The (b)(4) analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[45862208]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00554 |
| MDR Report Key | 5619610 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-04-29 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-03-10 |
| Date Mfgr Received | 2016-03-10 |
| Date Added to Maude | 2016-04-29 |
| 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 | 2016-04-29 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-29 |