MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-05 for AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE B12183 manufactured by Beckman Coulter.
[15782348]
The customer reported sporadic low sodium (na) results and occasionally low chloride (cl) values, on separate days, involving the au480 clinical chemistry analyzer with ise. The customer stated subsequent testing recovered acceptable sodium results. The customer performed system troubleshooting but could not resolve the issue. The low results were released out of the laboratory and questioned by the physician. There was no report of patient injury or change in patient treatment associated with this event. The customer indicated quality control (qc) was within specifications during the event. Beckman coulter field service engineer (fse) was dispatched to evaluate the instrument. This is report one of two.
Patient Sequence No: 1, Text Type: D, B5
[15800507]
The field service engineer (fse) replaced the pinch valve, drain, and ion selective electrolyte (ise) tubing set. The fse also replaced the electrodes and sample probe. The fse performed three consecutive successful calibrations and completed mid solution rest. The fse replaced the detergent roller pump tubing and drained the detergent bottle. The fse performed quality control (qc) successfully. Service activity performed was verified to meet the specified requirements per established procedures. The instrument conformed to the manufacturer's published specifications. This medwatch report is related to mdr 9612296-2013-00013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00012 |
| MDR Report Key | 2944714 |
| Report Source | 05,06 |
| Date Received | 2013-02-05 |
| Date of Report | 2013-01-10 |
| Date of Event | 2013-01-09 |
| Date Mfgr Received | 2013-01-10 |
| Device Manufacturer Date | 2012-01-02 |
| Date Added to Maude | 2013-04-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 BLVD. |
| 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, SUNTO-GUN |
| Manufacturer City | SCHIZUOKA, P-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 | AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2013-02-05 |
| Model Number | NA |
| Catalog Number | B12183 |
| 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 | 2013-02-05 |