MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-05-23 for MODULAR ANALYTICS E MODULE E170 03023109001 manufactured by Roche Diagnostics.
[626807]
Pt sample drawn in 2007 tested for total and free psa using 2 different methods with results as follows: initial method total psa 0. 188 ng/ml, free psa 4. 11 ng/ml. Second method: total psa 0. 141 ng/ml, free psa 0. 059 ng/ml. A new sample from the same pt was tested the next month and gave the following results: initial method total psa 0. 170 ng/ml, free psa 3. 52 ng/ml. Second method: total psa 0. 209 ng/ml, free psa 0. 068 ng/ml. If add'l info is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2007-04418 |
| MDR Report Key | 855252 |
| Report Source | 05,06 |
| Date Received | 2007-05-23 |
| Date of Report | 2007-05-23 |
| Date of Event | 2007-04-26 |
| Date Facility Aware | 2007-05-13 |
| Report Date | 2007-05-13 |
| Date Mfgr Received | 2007-05-13 |
| Date Added to Maude | 2007-06-07 |
| 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 | FERN DELACROIX |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217494 |
| Manufacturer G1 | HITACHI HIGH TECH CORP |
| Manufacturer Street | 882 ICHIGE HITACHINAKA |
| Manufacturer City | IBARAKI 08 312 |
| Manufacturer Postal Code | 08 312 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODULAR ANALYTICS E MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER - JJE |
| Product Code | NAF |
| Date Received | 2007-05-23 |
| Model Number | E170 |
| Catalog Number | 03023109001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 844556 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-23 |