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 2016-03-31 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[41564336]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[41564337]
The customer received a questionable free psa result from analytic e module serial number (b)(4). The initial total psa result was 6. 67 ng/ml and the free psa result was 10. 05 ng/ml. The repeat total psa result was 6. 73 ng/ml and the repeat free psa result was 2. 54 ng/ml. Information concerning if any erroneous result was reported outside the laboratory was requested, but it was unknown. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[44458119]
A specific root cause could not be identified. Sample from the patient was submitted for investigation. The issue could not be reproduced and no specific interference was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00390 |
| MDR Report Key | 5538024 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-31 |
| Date of Report | 2016-05-02 |
| Date of Event | 2016-03-17 |
| Date Mfgr Received | 2016-03-18 |
| Date Added to Maude | 2016-03-31 |
| 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 | 2016-03-31 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 188436 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-03-31 |