MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-06-19 for ABL700 SERIES ABL735 * manufactured by Radiometer Medical Aps.
[462287]
During blood gas measurement on an abl735 blood gas analyser, the customer considered that baby samples resulted in too high bilirubin values (ctbil). High ctbil may lead to wrong diagnosis and treatment. Service rep. Has conducted oxi-tests, patient thb calibration, quality checks and calibration. All passed. Two other patients were tested and also considered to have too high ctbil. At investigation of the hemolyzer, a substance was observed in the hemolyzer cuvette. After replacement of the hemolyzer, the customer made crosscheck and found the analyzer ok. Babies were transferred to another hospital for treatment. Measurement of ctbil at this hospital was considered acceptable. None of the patients were treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00031 |
| MDR Report Key | 730799 |
| Report Source | 01 |
| Date Received | 2006-06-19 |
| Date of Report | 2006-06-16 |
| Date of Event | 2006-05-16 |
| Date Mfgr Received | 2006-05-29 |
| Date Added to Maude | 2006-07-05 |
| 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 | GERT NIELSEN |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273057 |
| 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 SERIES |
| Generic Name | * |
| Product Code | CCE |
| Date Received | 2006-06-19 |
| Model Number | ABL735 |
| Catalog Number | * |
| 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 | 719087 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
| Baseline Brand Name | ABL735 |
| Baseline Generic Name | BLOOD GAS ANALYSER WITH ADDITIONAL PARAMETERS |
| Baseline Model No | ABL735 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-19 |