MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-18 for ETI-MAX 3000 6350 REF-9163500001 manufactured by Diasorin Inc.
[1900899]
Discovered that the eti-max 3000 by diasorin has software that allows operators to edit quality control data after analysis. Problem was discovered on (b)(6) 2010, when quality control and pt reports were being reviewed. Diasorin's tech support guided the supervisor to a drop-down menu allowing editing of data which had not met criteria. Dates of use: (b)(6) 2006 -- (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019076 |
| MDR Report Key | 1969334 |
| Date Received | 2011-01-18 |
| Date of Report | 2011-01-18 |
| Date of Event | 2010-09-28 |
| Date Added to Maude | 2011-02-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETI-MAX 3000 |
| Generic Name | CLINICAL TESTING INSTRUMENT FOR ASSAYS |
| Product Code | JJF |
| Date Received | 2011-01-18 |
| Model Number | 6350 |
| Catalog Number | REF-9163500001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIASORIN INC |
| Manufacturer Address | PO BOX 285 STILLWATER MN 55082028 US 55082 0285 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-18 |