MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-07-17 for ABL700 ABL735 393-725 manufactured by Radiometer Medical Aps.
[490027]
A too low na-value was measured on an abl735 blood gas analyzer. No alarm was issued. The low na value may have been caused by a defective reference electrode. Allegedly 4 or 5 patients were inappropriately treated for too low na values in the bloodstream. No serious injury or death has been reported as a consequence of these treatments.
Patient Sequence No: 1, Text Type: D, B5
[7794184]
The hospital alleges the reference membrane is drifting after 4 or 5 days. Additional tests are undertaken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2006-00036 |
| MDR Report Key | 743489 |
| Report Source | 01 |
| Date Received | 2006-07-17 |
| Date of Report | 2006-07-14 |
| Date of Event | 2006-06-16 |
| Date Added to Maude | 2006-08-04 |
| 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 | PIERRE PELLETIER |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273614 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL700 |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | CCE |
| Date Received | 2006-07-17 |
| Model Number | ABL735 |
| Catalog Number | 393-725 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 731285 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-17 |