MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for ORCHARD SOFTWARE - HARVEST manufactured by Orchard Software Corporation.
[44132876]
Lis malfunction - two techs were working on the same result at the same time. Sid urine creat was first resulted by the analyzer as >346. 0. One tech put the sample back on the analyzer for a rerun. The sample was now resulted and sent to the lis as 417. 0. One tech was looking at an unrefresh screen and saw >346. 0. That teach cleared it out (incorrectly causing it to read 0. 00. ) the other tech approved what she was seeing on her screen, the 417. 0 result. The pt's report reads <1. 2. (there is a rule in orchard to report a 0. 0 result as <1. 2). How does the report show <1. 2 with no initials when hs resulted it as 417. 0?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061974 |
| MDR Report Key | 5619454 |
| Date Received | 2016-04-01 |
| Date of Report | 2016-03-22 |
| Date of Event | 2016-01-25 |
| Date Added to Maude | 2016-04-29 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORCHARD SOFTWARE - HARVEST |
| Generic Name | HARVEST LIS |
| Product Code | GKL |
| Date Received | 2016-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORCHARD SOFTWARE CORPORATION |
| Manufacturer Address | 701 CONGRESSIONAL BLVD SUITE 360 CARMEL IN 46032 US 46032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-01 |