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 2019-05-02 for ABL90 FLEX PLUS ANALYZER 393-092 manufactured by Radiometer Medical Aps.
[146362106]
According to the complaint received, a customer reported to have intermittent patient barcode labelling issues on an abl90 flex analyzer. The following cases were observed when different patient labels were scanned: only some of the digits in the medical record number (mrn) was detected and one of the digits was incorrect. The patient name was correct. The mnr is correctly detected. But the patient name is not detected. Based on the current investigation performed in r&d, the issue seems to be related to the patient demographic rather than the reading of the barcode. New data of the issue has been requested by radiometer to perform further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2019-00016 |
| MDR Report Key | 8572625 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-02 |
| Date of Report | 2019-06-14 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-05-20 |
| Device Manufacturer Date | 2018-07-13 |
| Date Added to Maude | 2019-05-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | EZ |
| 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 | 2019-05-02 |
| 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 | 2019-05-02 |