MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-12-16 for ANALYTICAL E MODULE 03739040001 manufactured by Roche Diagnostics.
[1517352]
Customer reported an erroneous folate result of 19. 01 ng per ml for one patient sample. Same sample was run on a cobas e601 analyzer which recovered 6 ng per ml. On (b) (6) 2009, customer ran same sample on an e170 analyzer which recovered 5. 97 ng per ml. The sample type was serum. Patient was not treated or adversely affected due to the original result. The field service representative was unable to determine a cause. To verify analyzer performance, he completed performance tests with no discrepancies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2009-08504 |
| MDR Report Key | 1564501 |
| Report Source | 05,06 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-12-16 |
| Date of Event | 2000-12-02 |
| Date Facility Aware | 2009-12-03 |
| Report Date | 2009-12-03 |
| Date Mfgr Received | 2009-12-03 |
| Date Added to Maude | 2010-02-12 |
| 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 | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| 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- JJE |
| Product Code | OMM |
| Date Received | 2009-12-16 |
| Model Number | E MODULE |
| Catalog Number | 03739040001 |
| 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 | 2009-12-16 |