MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-04-07 for ABL 700 SERIES * manufactured by Radiometer Medical Aps.
[456890]
They sometimes measures unrealistic high values of cohb and therefore they do not use their measurments for this parameter. In most patients, the results from blood gaz analysis will be correct, but there are cases with patients who has increased dyshemoglobin fractions, and therefore the measured value cannot be used. The problem is described in the following article: clinical chemistry 51:2 434-444,2005 no previous events has been detected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00021 |
| MDR Report Key | 697796 |
| Report Source | 01 |
| Date Received | 2006-04-07 |
| Date of Report | 2006-02-24 |
| Date of Event | 2006-02-24 |
| Date Mfgr Received | 2006-02-24 |
| Date Added to Maude | 2006-04-12 |
| 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 | 0 |
| Manufacturer Contact | LISE-LOTTE RINGBY |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | 8273495 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL 700 SERIES |
| Generic Name | BLOOD GAZ ANALYSIS |
| Product Code | CCE |
| Date Received | 2006-04-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 686885 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly | 2006-04-07 |