MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-19 for ABL90 FLEX PLUS ANALYZER 393-092 manufactured by Radiometer Medical Aps.
[140156987]
According to the complaint received, an intensive care unit reported discrepant na+ results on an abl90 flex plus analyzer for multiple patient results measured (b)(6) 2019 despite of approved controls. A number of samples were measured on two abl90 flex analyzers (1 and 2), see the measurements in the table below: (b)(6). Based on the measurements above the abl90 flex analyzer 2 demonstrated increased measurement results compared to comparison measurements performed on the other abl90 flex analyzer 1. All checks performed in this period on both analyzers were ok. The solution pack on the abl90 flex analyzer 2 was consequently replaced, which stabilized the measurements on the abl90 flex analyzer 2 again. The customer complaints that the abl90 flex analyzer 2 provided false high na+ results while the controls were approved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2019-00007 |
| MDR Report Key | 8349485 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-19 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2019-02-19 |
| 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 | 3 |
| Manufacturer Contact | MS. BOLETTE DUUN-CHRISTENSEN |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL90 FLEX PLUS ANALYZER |
| Generic Name | ABL90 FLEX PLUS ANALYZER |
| Product Code | MQM |
| Date Received | 2019-02-19 |
| Model Number | 393-092 |
| Catalog Number | 393-092 |
| 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 | AAKANDEVEJ 21 BROENSHOEJ, 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |