MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2005-09-15 for ABL 7000 SERIES ABL735 * manufactured by Radiometer Medical Aps.
[21583961]
The pt was receiving a treatment iwth 10% dextrose, when a reading correctly showed 23 mmol/liter glucose in the blood. A reduced amount of dextrose was decided but not done. Later the medical staff incorrectly read a valid glucose result of 55 mmol/liter as 5. 5 mmol/liter and assumed wrongly the reduced dose was effected. This resulted in a continued 10% dextrose treatment. No other treatment was given. The pt died. The medicall staff has taken full responsibility for the pt death. The event happened in february 2004, exact date unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2004-00023 |
| MDR Report Key | 636275 |
| Report Source | 01,05,06 |
| Date Received | 2005-09-15 |
| Date of Report | 2004-12-10 |
| Date Added to Maude | 2005-09-23 |
| 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 | LEIF GUDNITZ |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Manufacturer Phone | 8273228 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL 7000 SERIES |
| Generic Name | BLOOD GAS ANALYZER WITH ADD, PARAMETERS |
| Product Code | CCE |
| Date Received | 2005-09-15 |
| 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 | 625815 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| 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 | 1. Death | 2005-09-15 |