MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-12-15 for ANALYTICAL E MODULE 03023109001 manufactured by Roche Diagnostics.
[16035658]
User experienced a low total psa result for one pt. Initial result gave 0. 003 ng/ml. The same sample was repeated five times in 2008 giving 100 ng/ml (accompanied by a flag instructing the user to rerun the sample), 4443 ng/ml (diluted), 1000 ng/ml (diluted and accompanied by a flag instructing the user to rerun the sample), 4343 and 4333 ng/ml (both diluted). The doctor questioned the result based on previous elevated results. Pt treatment was not altered. If additional info is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2008-09213 |
| MDR Report Key | 1336362 |
| Report Source | 05,06 |
| Date Received | 2008-12-15 |
| Date of Report | 2008-12-15 |
| Date of Event | 2008-11-06 |
| Date Facility Aware | 2008-11-27 |
| Report Date | 2008-11-27 |
| Date Mfgr Received | 2008-11-27 |
| Date Added to Maude | 2009-10-19 |
| 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 | SALLY BOWDEN |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214668 |
| Manufacturer G1 | HITACHI HIGH TECH. CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANALYTICAL E MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NAF |
| Date Received | 2008-12-15 |
| Model Number | E MODULE |
| Catalog Number | 03023109001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-15 |