MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-28 for INVISION manufactured by Siemens.
[1626025]
The spreadsheet display of results of blood tests from the clinical laboratory does not align all of the results of the various tests performed on the same day in one column. Thus, even though a test is not performed today, as a example, the most recent result, even if from a week ago, will appear labeled as having been one week ago, but appears on the display on the far left, in a column that includes the most recent blood tests of today. At quick glance, it appeared that the inr monitoring of the anticoagulation was current, because, it appeared in the same column as electrolytes done today, when in fact, it had been done a week ago. This deceived the user daily for three days in a row and no inr monitoring was done. The pt became minimally over anti-coagulated, but the risk is there for severe harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016846 |
| MDR Report Key | 1781521 |
| Date Received | 2010-07-28 |
| Date of Report | 2010-07-28 |
| Date of Event | 2010-07-26 |
| Date Added to Maude | 2010-08-05 |
| 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 |
| 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 | INVISION |
| Generic Name | MDDS |
| Product Code | LMD |
| Date Received | 2010-07-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Manufacturer Address | MALVERN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-07-28 |