MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-04-10 for ABL700 ABL735 * manufactured by Radiometer Medical Aps.
[456271]
The customer has tested the abl735 with a reference instrument (modular) and observed that abl735 measures lower bilirubin concentrations than modular. Neonates with a too high concentration of bilirubin may need light therapy or exchange transfusion. If the ctbil-values shown by the device are ower than the actual values, the measurements may affect this diagnosis resulting in delayed necessary treatment. Healthcare personnel will get other indications of the problem, because the skin is turning yellow (jaundice) but it may not possible to evaluate the degree of the problem exactly based on the colour. Measurements has been provided all indicating lower values for abl700.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00023 |
| MDR Report Key | 699823 |
| Report Source | 01 |
| Date Received | 2006-04-10 |
| Date of Report | 2006-04-10 |
| Date of Event | 2006-02-27 |
| Date Mfgr Received | 2006-02-27 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2006-04-17 |
| 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 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 |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | CCE |
| Date Received | 2006-04-10 |
| 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 | 688913 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * BRONSHOJ DA |
| 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 | 2006-04-10 |