MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-01-07 for ABL 90 FLEX SC90 -600 TESTS 946-008 manufactured by Radiometer Medical Aps.
[1815989]
The analyzer yielded false pt results for blood measurements because of a malfunctioning sensor cassette. A comparison of pt data from this instrument and another abl90 showed a bias of -9 mmol for sodium, -0. 1 mmol for calcium, -0. 2 mmol for potassium, +0. 018 for ph and +7 mmol for chloride.
Patient Sequence No: 1, Text Type: D, B5
[8865147]
Data analysis from the instrument shows that the malfunction was caused by a bias on the reference electrode in the sc, which was quickly built up after installation of the sc. The failing sensor cassette was retrieved from the customer site and is currently being tested in r&d. Once the investigation is completed, the results will be submitted in a f/u report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2011-00001 |
| MDR Report Key | 1979805 |
| Report Source | 01,05 |
| Date Received | 2011-01-07 |
| Date of Report | 2010-12-09 |
| Date of Event | 2010-12-08 |
| Date Mfgr Received | 2010-12-09 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2011-02-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LASSE MOLLER, SPECIALIST |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 4538273436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL 90 FLEX |
| Generic Name | BLOOD GAS ANALYSER |
| Product Code | JFP |
| Date Received | 2011-01-07 |
| Returned To Mfg | 2010-12-22 |
| Model Number | SC90 -600 TESTS |
| Catalog Number | 946-008 |
| Lot Number | R0031 |
| Device Expiration Date | 2011-03-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-01-07 |