MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-02-27 for BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER AU681-10E B12188 manufactured by Beckman Coulter.
[17158183]
The customer reported generating high potassium (k) results from the beckman coulter au680 clinical chemistry analyzer. The customer reported obtaining erroneously high k results for three (3) patients. The customer reported obtaining erroneously high k results for three (3) patients, but provided only one verbal example of a k result of 8 mmol/l which recovered a result of 4 mmol/l upon repeat. No erroneous results were generated out of the laboratory and there was no change or affect to patient treatment in connection with this event. The customer did not provide any instrument printouts or patient demographics information for this event.
Patient Sequence No: 1, Text Type: D, B5
[17550380]
(b)(6). A beckman coulter customer technical support (cts) assisted the customer with troubleshooting over the telephone. The cts advised the customer to replace the sample probe and potassium (k) electrode to resolve the issue. A field service engineer (fse) was then dispatched to the customer's site. The fse verified the repairs performed by the customer by carrying out a precision run, and checking the calibration slopes which passed published specifications. In conclusion, the most likely cause of the event is attributed to a k electrode malfunction. The k electrode was replaced by the customer and the customer has not reported of any further issues related to this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2014-00039 |
| MDR Report Key | 3652198 |
| Report Source | 01,05,06 |
| Date Received | 2014-02-27 |
| Date of Report | 2014-02-05 |
| Date of Event | 2014-02-05 |
| Date Mfgr Received | 2014-02-05 |
| Device Manufacturer Date | 2013-04-22 |
| Date Added to Maude | 2014-05-12 |
| 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, SHIZUOKA, JP-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 | BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2014-02-27 |
| 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 | 2014-02-27 |