MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-02-08 for ABL90 FLEX ANALYZER 393-090 manufactured by Radiometer Medical Aps.
[136792997]
Data from the affected abl90 flex analyzer (serial number: (b)(4)) was provided from the customer to radiometer for investigation. Data from the abl90 flex analyzer (serial number: (b)(4)) used for comparison measurements has also been requested from customer, which currently is pending.
Patient Sequence No: 1, Text Type: N, H10
[136792998]
According to the complaint received, a customer reported consistent varying patient measurements for the thb parameter on an abl90 flex analyzer ((b)(4)). Examples of the deviations for the thb parameter are shown below for several sequences of measurements. (b)(6). The samples are taken from the same syringe. It should be noticed that for some of the pairwise measurements the comparison measurements were performed on the same analyzer see the measurements from (b)(6) 2018 in the table above.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2019-00005 |
| MDR Report Key | 8319702 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-08 |
| Date of Report | 2019-09-25 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2019-09-23 |
| Device Manufacturer Date | 2012-04-11 |
| Date Added to Maude | 2019-02-08 |
| 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 ANALYZER |
| Generic Name | ABL90 FLEX ANALYZER |
| Product Code | CEM |
| Date Received | 2019-02-08 |
| Model Number | 393-090 |
| Catalog Number | 393-090 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-02-08 |