MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-27 for HCLL TRANSFUSION 2013 manufactured by Mediware Information Systems.
[4575101]
Hcll transfusion 2013 interface was configured by the user facility for only one type of test results from a provue instrument. When more than one test result was received in a single data file, the interface conversion from test result to hcll entry was based on the first one in the data file. The user experienced the incorrect reporting when aborh results were received for the absc from the interface engine, but within the hcll application the rh interpretation result was used for the absc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006129391-2014-00001 |
| MDR Report Key | 3941131 |
| Report Source | 06 |
| Date Received | 2014-05-27 |
| Date of Report | 2014-05-22 |
| Date of Event | 2014-05-16 |
| Date Mfgr Received | 2014-05-16 |
| Date Added to Maude | 2014-07-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JON MOECKEL |
| Manufacturer Street | 11711 WEST 79TH STREET |
| Manufacturer City | LENEXA KS 66214 |
| Manufacturer Country | US |
| Manufacturer Postal | 66214 |
| Manufacturer Phone | 9133071051 |
| Manufacturer G1 | MEDIWARE INFORMATION SYSTEMS INC. HEADQUARTERS |
| Manufacturer Street | 11711 WEST 79TH STREET |
| Manufacturer City | LENEXA KS 66214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 66214 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HCLL TRANSFUSION 2013 |
| Generic Name | HCLL TRANSFUSION 2013 |
| Product Code | MMH |
| Date Received | 2014-05-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIWARE INFORMATION SYSTEMS |
| Manufacturer Address | 11711 WEST 79TH STREET LENEXA KS 66214 US 66214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-27 |