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 2004-09-23 for ABL700 SERIES ABL735 * manufactured by Radiometer Medical Aps.
[15219866]
The instrument reported incorrectly a low ph-value. The patient was treated wrongly for low ph-value with bicarbonate. Using another analyzer the erroneous result was discovered, and the treatment stopped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2004-00002 |
| MDR Report Key | 546047 |
| Report Source | 01,05,06 |
| Date Received | 2004-09-23 |
| Date of Report | 2004-09-08 |
| Date of Event | 2004-05-29 |
| Date Mfgr Received | 2004-06-03 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2004-09-29 |
| 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, QUAL CONSULTANT |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | ** |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL700 SERIES |
| Generic Name | BLOODGAS ANALYZER WITH ADDITIONAL PARAMETERS |
| Product Code | CCE |
| Date Received | 2004-09-23 |
| 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 | 535455 |
| 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 | 2004-09-23 |