MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-10 for AU680 CLINICAL CHEMISTRY ANALYZER AU681-10E B12188 manufactured by Beckman Coulter, Inc.
[44886880]
A beckman field service engineer (fse) was dispatched and evaluated the system. The fse identified a faulty syringe driver assembly. The fse replaced the syringe driver to resolve the issue. No further issues were noted. This mdr type of reportable event is both malfunction and serious injury. The full bec patient identifier for this event is (b)(6). All associated mdr: 9612296-2016-00058, 9612296-2016-00060, 9612296-2016-00061, 9612296-2016-00062, and 9612296-2016-00064. Patient demographics were not provided for the patients that had change to treatment.
Patient Sequence No: 1, Text Type: N, H10
[44886881]
The customer reported obtaining erroneous results for multiple assays including low magnesium (mag) results for five patient samples involving the au680 clinical chemistry analyzer. Erroneous results were reported out of the laboratory. While most patients had no change to treatment, this mdr reports this event for patient 4 of five patients that were treated for the low mag with iv (intravenous) or orally administered dose of magnesium. Customer provided no specifics as to which patients received change to treatment. Customer stated that control (qc) recovery demonstrated failing recovery on multiple assays as well. Customer could not resolve the issue. The customer ceased use of the instrument until service arrived. All samples were retested on an alternate au680 and amended results were issued. There has been no report of any adverse consequences noted for this patient that was treated for the low mag results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612296-2016-00063 |
| MDR Report Key | 5644617 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-10 |
| Date of Report | 2016-04-15 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2016-04-15 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2016-05-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE.01 |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| 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 | AU680 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | CFA |
| Date Received | 2016-05-10 |
| Model Number | AU681-10E |
| Catalog Number | B12188 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-10 |