MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-04-11 for AU5800 CLINICAL CHEMISTRY ANALYZER AU5811-03 A94908 manufactured by Beckman Coulter.
[4553353]
The customer reported that the au5800 clinical chemistry analyzer generated erroneous potassium (k) results for multiple patients. The erroneous results were not reported out of the laboratory and there was no change or affect to patient treatment in connection with this event. The customer provided ten (10) discrepant patient results which are outside of the assay specification for this event. The customer stated that plasma residue was discovered on the ion selective electrode (ise) dilution pot. The customer also found a kinked tubing from the dilution pot to the flowcell and suspected that this was the cause of the plasma residue on the inside surface of the dilution pot as the kinked tubing would prevent the ise dilution pot from draining or cleaning. The customer put in place a temporary measure to prevent the tubing from re-kinking. The customer then cleaned the dilution pot, calibrated the assays, and ran quality controls (qc). The customer reported that the instrument operated within specifications at this time. However, after running four (4) hourly qcs, the customer noticed that the potassium qc results recovered out of range.
Patient Sequence No: 1, Text Type: D, B5
[11738204]
(b)(6). A field service engineer (fse) was dispatched to the customer's site. The fse evaluated the instrument and discovered a bent mix paddle/bar in the ise dilution pot which was causing splashes of residue on the surface of the dilution pot. The fse cleaned the residue and replaced the mix paddle/bar and other consumable parts on the ise unit. The fse verified operation of the ise unit by performing calibration and running a precision run and qc. The fse obtained passing results which met published specifications. In conclusion, failure mode of the event is attributed to a bent mix paddle/bar in the ise dilution pot. Results : ise dilution pot mix paddle/bar.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2014-00066 |
| MDR Report Key | 3747051 |
| Report Source | 01,05,06 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-03-17 |
| Date of Event | 2014-03-16 |
| Date Mfgr Received | 2014-03-17 |
| Device Manufacturer Date | 2012-10-04 |
| Date Added to Maude | 2014-06-05 |
| 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, SHIZUOKA, 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 | MZV |
| Date Received | 2014-04-11 |
| Model Number | AU5811-03 |
| Catalog Number | A94908 |
| 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 | 2014-04-11 |