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 2019-01-29 for ABL90 FLEX PLUS ANALYZER 393-092 manufactured by Radiometer Medical Aps.
[136614244]
Please note that no udi number is available for this affected device. The udi number is blank, as this product was manufactures before udi numbers was implemented at radiometer.
Patient Sequence No: 1, Text Type: N, H10
[136614465]
According to the complaint received, a deviation for more than 50% was observed for the bilirubin parameter on abl90 flex plus analyzer placed in the delivery room. Two samples were measured at clinic, where the problem was reported ((b)(6)) and compared to measurements performed in the laboratory and measurements performed at another clinic ((b)(6)). The following bilirubin results were measured: sample 1 -(b)(6): 67 umol/l, abl90 flex analyzer. Sample 1 -(b)(6) (laboratory): 71 umol/l, abl90 flex analyzer. Sample 1 -(b)(6) (delivery room): 24 umol/l, abl90 flex plus analyzer. Sample 2 -(b)(6): 74 umol/l, abl90 flex analyzer. Sample 2 -(b)(6) (lab): 68 umol/l, abl90 flex analyzer. Sample 2 -(b)(6) (delivery): 17 umol/l, abl90 flex plus analyzer. Based on the above measurement it was reported that the abl90 flex plus analyzer in the delivery room demonstrated a low bias for more than <50% compared to the measurements performed on abl90 flex analyzers. There was no reports of serious injury or maltreatment in relation to this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2019-00003 |
| MDR Report Key | 8284492 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-29 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-02-07 |
| Device Manufacturer Date | 2015-10-13 |
| Date Added to Maude | 2019-01-29 |
| 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 | 2019-01-29 |
| Model Number | 393-092 |
| Catalog Number | 393-092 |
| 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 | AAKANDEVEJ 21 BROENSHOEJ, 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |