MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-02-21 for BLOODGAS ANALYZER, ABL 800 SERIES * manufactured by Radiometer Medical Aps.
[403203]
A sample was analyzed on the blood gas analyzer this sampler or a sample analyzed prior to this measurement introduced a clot in the blood gas analyzer. The clot was positioned in the ph chamber during measurement of sample the clot in the ph chamber led to too low ph values. For sample the ph value had not been requested. Clots may affect the sample transport and may alson lead to dilution of the sample. When a technician removed the clot the problem solved. The ph electrode was cleaned. Quality control (qc level 3+) was done, without any problem. Due to the wrong ph measurement a patient was mistreated with nabic. The patient has not suffered any degradation in state of health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00015 |
| MDR Report Key | 680977 |
| Report Source | 05 |
| Date Received | 2006-02-21 |
| Date of Report | 2006-02-06 |
| Date of Event | 2006-01-05 |
| Date Mfgr Received | 2006-01-05 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2006-03-03 |
| 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 | LISE-LOTTE RINGBY |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | 8273495 |
| 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 | BLOODGAS ANALYZER, |
| Generic Name | BLOODGAS ANALYZER |
| Product Code | CCE |
| Date Received | 2006-02-21 |
| Model Number | ABL 800 SERIES |
| Catalog Number | * |
| Lot Number | 754R0023N0005 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 670248 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 * DA DK-2700 |
| Baseline Brand Name | BLOODGAS ANALYZER, |
| Baseline Generic Name | BLOODGAS ANALYZER |
| Baseline Model No | ABL 800 SERIES |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-02-21 |