MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-02 for OLYMPUS AU681-10E (AU680 SERIES) WITH ISE CLINICAL CHEMISTRY ANALYZER B12188 manufactured by Beckman Coulter.
[21310956]
A customer contacted beckman coulter (bec) reporting a high potassium (k) result for one (1) patient sample was generated on the olympus (b)(4) (au680 series) with ion selective electrode (ise) clinical chemistry analyzer. Upon repeat the result recovered within normal range. The erroneously high result was not reported out of the laboratory. The results provided by the customer are shown in this report. Patient demographics (age, date of birth, gender, and weight) were not provided by the customer. There were no reports of patient injury requiring medical intervention or change to patient treatment attributed to or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
[21568431]
No sample collection or preparation information was supplied. Calibration data showed all electrodes were within tolerance before the reported event. In addition, selectivity for sodium and potassium were within normal range prior to the reported event. Quality control (qc) was run prior to and after the event and recovered within the expected range. A bec field service engineer (fse) was dispatched on 09/10/2013 for this event. The fse replaced the ion selective electrode (ise) valve which resolved the issue. No further issues were seen after the replacement of the ise reference valve.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2013-00139 |
| MDR Report Key | 3382429 |
| Report Source | 05,06 |
| Date Received | 2013-10-02 |
| Date of Report | 2013-09-10 |
| Date of Event | 2013-09-09 |
| Date Mfgr Received | 2013-09-10 |
| Device Manufacturer Date | 2012-10-17 |
| Date Added to Maude | 2014-01-08 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS AU681-10E (AU680 SERIES) WITH ISE CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2013-10-02 |
| Model Number | AU681-10E |
| 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 BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-02 |