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 700 SERIES ABL 725 * manufactured by Radiometer Medical Aps.
[19244208]
Over a period of 3 months hosp reported intermittent low sodium results; specifically, they reported that 240 samples were below the normal range of 130 mmol/liter out of approx 25,000 samples. Out of the 240 samples, 14 samples were low by 6 - 17 mmol/liter compared to a different analyzer. Additionally a sample differed by 17 mmol/liter on two identical abl analyzers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2004-00014 |
| MDR Report Key | 654961 |
| Report Source | 01,05,06 |
| Date Received | 2005-09-15 |
| Date of Report | 2004-12-10 |
| Date Mfgr Received | 2003-04-25 |
| Date Added to Maude | 2005-12-22 |
| 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, QUALITY CONSULTA |
| 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 700 SERIES |
| Generic Name | BLOOD GAS ANALYZER WITH ADDITIONAL PARAMETER |
| Product Code | CCE |
| Date Received | 2005-09-15 |
| Model Number | ABL 725 |
| 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 | 644444 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| Baseline Brand Name | BLOODGAS ANALYZER |
| Baseline Generic Name | ABL 700 SERIES AND ABL 800 SERIES |
| Baseline Model No | ABL 725 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-15 |