MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-25 for AU680 CLINICAL CHEMISTRY ANALYZER AU681-10E B12188 manufactured by Beckman Coulter.
[4246569]
A customer stated they generated 2 erroneously high potassium results on their au680 analyser. These results were not reported outside of the laboratory so there was no reported change to patient treatment. According to the customer, quality control runs were within specification and all required maintenance had been performed on the ise unit.
Patient Sequence No: 1, Text Type: D, B5
[11594192]
A field service engineer (fse) was dispatched. The fse found large amount of bubbles coming from the reference valve. The fse replaced the reference valve with part no. B37620. The fse primed the system and confirmed there were no further bubbles coming from the valve. A calibration and qc were performed and the system was confirmed to be performing with specification. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2014-00052 |
| MDR Report Key | 3699621 |
| Report Source | 05,06 |
| Date Received | 2014-03-25 |
| Date of Report | 2014-03-08 |
| Date of Event | 2014-03-08 |
| Date Mfgr Received | 2014-03-08 |
| Device Manufacturer Date | 2012-03-09 |
| Date Added to Maude | 2014-05-22 |
| 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 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, SCHIZUOKA 411-093 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-093 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-08/22/2013-008 |
| 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 | 2014-03-25 |
| 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 BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-25 |