MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-03 for AU5800 CLINICAL CHEMISTRY ANALYZER AU5821-02 A94912 manufactured by Beckman Coulter.
[15015308]
The customer alleged obtaining intermittent low na (sodium) results on cell #1 involving the au5800 clinical chemistry analyzer. The au5800 has a dual ise (ion selective electrode) consisting of cell #1 and cell #2 which functions independently with the exception of a common sample dispense. The customer stated that "a few" patient samples were impacted but could not provide a definitive number of patient results which were affected. No results were reported out of the laboratory and there was no change or affect to patient treatment in connection with this event. The customer reported observing air in the ise lines while troubleshooting.
Patient Sequence No: 1, Text Type: D, B5
[15331720]
A beckman coulter fse (field service engineer) was dispatched and replaced the ise reference valve to rid air bubbles in the ise reference line. The fse inspected the ise system and proceeded to replace ise tubing line #5 and the sample d-pot when the fse discovered a chip in the cup. The fse completed the ise system check by removing and cleaning the ise flowcell. The instrument was calibrated and primed, and qc (quality control) was run following repairs. Qc results were within the established ranges and instrument's performance met published specifications. Failure mode is attributed to a failed ise reference valve.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00059 |
| MDR Report Key | 3092973 |
| Report Source | 05,06 |
| Date Received | 2013-05-03 |
| Date of Report | 2013-04-05 |
| Date of Event | 2013-04-05 |
| Date Mfgr Received | 2013-04-05 |
| Device Manufacturer Date | 2011-09-09 |
| Date Added to Maude | 2013-07-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO NAGAIZUMI-CHO |
| Manufacturer City | SUNTO-GUN, SCHIZUOKA, JP-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU5800 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | NGS |
| Date Received | 2013-05-03 |
| Model Number | AU5821-02 |
| Catalog Number | A94912 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-03 |