MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-31 for ABL700 SERIES 393-725 manufactured by Radiometer Medical Aps.
[15606838]
Data from a blood sample analyzed on an blood gas analyzer was displayed correctly on the monitor and transferred correctly to radiance. However, the next 10 print-outs was all including the data of this sample. The repeated print-out of the same sample could have resulted in mix-up of patient data. The operator noticed the mistake and no patients were mistreated as a result. At present, the cause of the incident is not clear. Investigation is continues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2007-00008 |
| MDR Report Key | 859478 |
| Report Source | 05 |
| Date Received | 2007-05-31 |
| Date of Report | 2007-05-31 |
| Date of Event | 2007-04-30 |
| Date Mfgr Received | 2007-05-01 |
| Date Added to Maude | 2007-07-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273827 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL700 SERIES |
| Generic Name | ALB725 |
| Product Code | CCE |
| Date Received | 2007-05-31 |
| Catalog Number | 393-725 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 855722 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-31 |