MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-12 for HCLL TRANSFUSION 2014 manufactured by Mediware Information Systems.
[38770986]
Following receipt of specimen from instrument, the application shifted the specimen value in the test worksheet to a different patient, resulting in the wrong blood type and/or absc result being displayed. Currently unable to reproduce the event. The event was originally reported (b)(6) 2015, further information was obtained, causing the case to be re-opened (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006129391-2016-00001 |
| MDR Report Key | 5433742 |
| Date Received | 2016-02-12 |
| Date of Report | 2016-02-11 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-02-01 |
| Device Manufacturer Date | 2015-04-10 |
| Date Added to Maude | 2016-02-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JON MOECKEL |
| Manufacturer Street | 11711 W 79TH ST. |
| Manufacturer City | LENEXA KS 66214 |
| Manufacturer Country | US |
| Manufacturer Postal | 66214 |
| Manufacturer Phone | 9133071051 |
| Manufacturer G1 | MEDIWARE INFORMATION SYSEMS |
| Manufacturer Street | 11711 W 79TH ST. |
| Manufacturer City | LENEXA KS 66214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 66214 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HCLL TRANSFUSION 2014 |
| Generic Name | HCLL TRANSFUSION 2014 |
| Product Code | MMH |
| Date Received | 2016-02-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2016-02-12 |