MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-04-26 for ABL700 AND 800 SERIES/RADIANCE ABL 725 393-725 manufactured by Radiometer Medical Aps.
[447532]
A blood gas analysis were made on a abl725 blood gas analyzer. The abl 725 showed a glucose value on approximately 320 mg/dl (17,8 mmol/l). A measurement report printed from a computer with the software radiance, showed a value of approximately 18 'mg/dl' (however, the correct unit and the read out of the abl725 was correct in mmol/l). The interpretation of the report showing the 18 'mg/dl' (wrong unit) was clinically interpreted as very low. This radiance report value of 18 'mg/dl' with an actual correct unit in mmol/l on the abl725 printout was used for the diagnose of the patient, and the patient were treated with medication (probably given glucose i. V. ) to get the glucose to rise. The correct value was 330 mg/dl or the 18,3 mmol/l printout of the abl725. The problem is related to the report printout layout in the radiance system. If the default -r- layout is used, the units will be taken from the database and actual value and units will match. It is, however, possible to hard code the units on the report form, which was done in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00026 |
| MDR Report Key | 707089 |
| Report Source | 06 |
| Date Received | 2006-04-26 |
| Date of Report | 2006-04-24 |
| Date of Event | 2006-04-05 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 2006-05-04 |
| 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 DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273827 |
| 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 AND 800 SERIES/RADIANCE |
| Generic Name | BLOOD GAS ANALYZER/RADIANCE |
| Product Code | CCE |
| Date Received | 2006-04-26 |
| Model Number | ABL 725 |
| Catalog Number | 393-725 |
| Lot Number | * |
| ID Number | PRODUCED 08-1998 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 696157 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA DK-2700 |
| 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. Death | 2006-04-26 |