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 2018-01-19 for AU5800 CLINICAL CHEMISTRY ANALYZER AU5800-10 B23279 manufactured by Beckman Coulter.
[97848620]
No patient demographics were provided. No actual printout data was provided but only verbal results. The repeats were performed on the same instrument but on a different cell. The patient treatment was changed on patient #1. The medication dosage was changed due to the high k result. However, customer didn't know what medication and what dosage was changed. Beckman coulter field service engineer (fse) indicated the main issue of the erratic k results was the lack of maintenance of the instrument. Fse indicated the instrument didn't have proper maintenance since oct 2017. Fse indicated the customer went through a significant management change that probably contributed to the lack of maintenance. Fse indicated the reagent and sample probes, reagent and sample syringes, and mix bars were all bad on the instrument. Fse replaced the above parts as well as the electrodes, roller tubing, and j tubing to bring the maintenance up to date. Fse also cleaned flow cell and ise (ion selective electrode) pot. Per au5800 ifu rev. A98352ac, page 6-28: daily maintenance included inspect the syringes for leaks and inspect, clean, and prime the sample probes, reagent probes, and mix bars. Evidence suggested the failure mode was use error for the lack of system maintenance. There was no evidence of a system malfunction.
Patient Sequence No: 1, Text Type: N, H10
[97848621]
The customer reported the au5800 clinical chemistry system had erratic erroneous potassium (k) results. Customer reported 6 out of 50 k results were erroneous results and reported outside of the lab. Customer indicated one patient treatment was changed. The patient received a change in medication dosage due to the high k result. Customer indicated the potassium quality controls (qc) were within the lab established ranges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612296-2018-00006 |
| MDR Report Key | 7206428 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-19 |
| Date of Report | 2017-01-01 |
| Date of Event | 2017-12-28 |
| Date Mfgr Received | 2018-01-01 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2018-01-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| 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. M/S E1.SE.01 |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K |
| Manufacturer Street | 454-32 HIGASHINO, NAGAIZUMI-CH SUNTO-GUN |
| Manufacturer City | SCHIZUOKA, JP-NOTA 411-0931 |
| Manufacturer Country | JA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU5800 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2018-01-19 |
| Model Number | AU5800-10 |
| Catalog Number | B23279 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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 | 1. Required No Informationntervention | 2018-01-19 |