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 2017-12-20 for FREE PSA 03289788190 manufactured by Roche Diagnostics.
[96032290]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[96032291]
The customer experienced an issue where the elecsys free psa immunoassay results were higher than the elecsys total psa immunoassay results for two patients. The customer used the cobas 8000 e 602 module serial number (b)(4). For patient 1 the free psa result was 2. 19 ng/ml and the total psa result was 0. 07 ng/ml. For patient 2 on (b)(6) 2017 the free psa result was 3. 7ng/ml and the total psa result was 0. 065 ng/ml. On (b)(6) 2017 the patient 2 sample was repeated with an automatic dilution and the free psa result was 3. 53 ng/ml. The patient 2 sample was tested using the siemens method and the free psa result was 0. 02 ng/ml and the total psa result was 3. 24 ng/ml. The customer believed the results from the siemens method. The results were reported outside of the laboratory. There was no allegation of an adverse event. This medwatch will cover the erroneous free psa results on the e 602 module. Patient identifier (b)(6) for information on the erroneous total psa results from the e 602 module.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-03051 |
| MDR Report Key | 7133019 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-20 |
| Date of Report | 2018-01-18 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2017-12-11 |
| Date Added to Maude | 2017-12-20 |
| 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 | 2017-12-20 |
| 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 | 2017-12-20 |