MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-22 for REMISOL ADVANCE (RADV) WORK STATION, US HW, RADV B25255 manufactured by Normand-info S.a.s.u..
[176281818]
Beckman coulter customer technical service (cts) evaluated the event, and identified the "validation range" settings were incorrect. The patient was one (1) day old and was not included in the "less that 1 day old" validation range. Cts confirmed that the rules ran as expected based on the "validation range" settings. The settings were adjusted to resolve the issue. Age or date of birth, weight, and ethnicity: information not provided by customer. (b)(6). The beckman coulter internal identifier is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[176281819]
The customer reported critical tbil (total bilirubin) results for an infant were auto validated by remisol advance (radv) when it should have not been auto validated, which caused a delay in patient treatment by one (1) day. There was no report of injury or death associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006543086-2020-00001 |
| MDR Report Key | 9617299 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-03 |
| Date Facility Aware | 2020-01-03 |
| Date Mfgr Received | 2020-01-03 |
| Date Added to Maude | 2020-01-22 |
| 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 | MRS. CHRISTINE XARDEL |
| Manufacturer Street | 7 RUE FREDERIC DEGEORGE BAT B 2 IEME ETAGE |
| Manufacturer City | ARRAS, 62000 |
| Manufacturer Country | FR |
| Manufacturer Postal | 62000 |
| Manufacturer G1 | NORMAND-INFO S.A.S.U. |
| Manufacturer Street | 7 RUE FREDERIC DEGEORGE BAT B 2IEME ETAGE |
| Manufacturer City | ARRAS PAS-DE-CALAIS, 62028 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 62028 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REMISOL ADVANCE (RADV) |
| Generic Name | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| Product Code | JQP |
| Date Received | 2020-01-22 |
| Model Number | WORK STATION, US HW, RADV |
| Catalog Number | B25255 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORMAND-INFO S.A.S.U. |
| Manufacturer Address | 7 RUE FREDERIC DEGEORGE BAT B 2 IEME ETAGE ARRAS, 62000 FR 62000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-22 |