MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-06 for CREATININE AU REAGENT CREATININE, R1 4 X 150 ML, R2 4 X 150 ML OSR6678 manufactured by Beckman Coulter.
[130179959]
The customer used a new cartridge of creatinine reagent to resolve the issue. The beckman coulter internal identifier is case-(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130179960]
The customer reported receiving erroneous creatinine patient results on the au680 clinical chemistry analyzer. The erroneous results were not reported outside of the lab. There was no change to patient treatment in association wit this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680746-2018-01001 |
| MDR Report Key | 8140070 |
| Date Received | 2018-12-06 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-06-27 |
| Date Facility Aware | 2018-06-27 |
| Date Mfgr Received | 2018-06-27 |
| Date Added to Maude | 2018-12-06 |
| 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 | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER IRELAND |
| Manufacturer Street | LISMEEHAN |
| Manufacturer City | O'CALLAGHAN MILLS |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CREATININE AU REAGENT |
| Generic Name | ALKALINE PICRATE, COLORIMETRY, CREATININE |
| Product Code | CGX |
| Date Received | 2018-12-06 |
| Model Number | CREATININE, R1 4 X 150 ML, R2 4 X 150 ML |
| Catalog Number | OSR6678 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-06 |