MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-05 for AU680 CLINICAL CHEMISTRY ANALYZER B12188 manufactured by Beckman Coulter.
[4145617]
A customer reported erroneous low potassium test results were obtained for one patient sample when using the au680 clinical chemistry analyzer. The customer stated that these results were not reported outside of the laboratory. There was no death, injury or affect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[11271114]
The customer observed bubbling within the reference block and were unsure of the source. The field service engineer (fse) evaluated the analyzer and verified the customer's observation. The fse replaced the ref (reference) valve and ise (ion selective electrode) tubing as a preventative measure. The fse then primed the ise and did not observe any bubbles. Calibrations, precision and qc were performed, with all results passing within specifications. Identification of failure mode: ref valve was replaced and bubbles were removed within the line.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00171 |
| MDR Report Key | 3501945 |
| Report Source | 05,06 |
| Date Received | 2013-12-05 |
| Date of Report | 2013-11-15 |
| Date of Event | 2013-11-15 |
| Date Mfgr Received | 2013-11-15 |
| Device Manufacturer Date | 2013-07-24 |
| Date Added to Maude | 2014-03-18 |
| 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 |
| Manufacturer City | SUNTO-GUN, SHIZUOKA, P-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 | AU680 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2013-12-05 |
| Model Number | NA |
| Catalog Number | B12188 |
| 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 | 2013-12-05 |