MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-21 for AU5431-02 CLINICAL CHEMISTRY ANALYZER N1464600 manufactured by Beckman Coulter.
[3313670]
A customer contacted beckman coulter (bec) to report lithium instability on a au5431-02 clinical chemistry analyzer. Per customer, six (6) patients were affected. One recovered low the other five recovered high. There was no injury or effect to patient treatment with regard to this event.
Patient Sequence No: 1, Text Type: D, B5
[10543672]
The customer was experiencing erratic values for lithium qc. There were no reported problems with calibration. A field service engineer (fse) was dispatched for this event. Fse found that the sample probes were too tight and the syringes had possibly been affected by that. Fse re-lubricated all assemblies and aligned probes. Fse also replaced tubing after a small leak was found in the wash water anti drip line. Fse continued to troubleshoot the system and replaced the sample transport assembly, sample solenoid valve, reagent solenoid valve, swapped reagent and sample syringe drivers, adjusted gear pump slightly, and verified alignments. However the issue was not resolved. Fse noted that this customer's lab humidity was less than 40%. The lab was also mixing tube types to include running 13mm nested cups on the analyzer. Fse then moved the lithium from the inner to the outer ring and recovery on the outer ring was reproducible without errors. There were no further issues since the test was located to the outer ring. A definite cause for this event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00044 |
| MDR Report Key | 3015267 |
| Report Source | 05,06 |
| Date Received | 2013-03-21 |
| Date of Report | 2013-02-20 |
| Date of Event | 2013-02-20 |
| Date Mfgr Received | 2013-02-20 |
| Device Manufacturer Date | 2005-08-11 |
| Date Added to Maude | 2013-05-22 |
| 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 |
| 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-CH SUNTO-GUN |
| Manufacturer City | SHIZUOKA, JP-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU5431-02 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NDW |
| Date Received | 2013-03-21 |
| Model Number | NA |
| Catalog Number | N1464600 |
| 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 | 2013-03-21 |