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 2013-12-11 for UNICEL? DXC 880I SYNCHRON ? ACCESS CLINICAL SYSTEM A59102 manufactured by Beckman Coulter.
[3960230]
The customer reported obtaining false high potassium (k) results for fourteen (14) patient samples from the unicel dxc 880i synchron access clinical system. The customer reported the results out of the laboratory and one (1) patient was treated based upon a false high k result. This report references the other thirteen (13) patients involved in this event; please refer to medwatch report #2050012-2013-00813 for the report of the patient who was treated. The customer repeated the samples on an alternate analyzer and issued amended reports. There was no change or affect to treatment for the thirteen patients referenced in this report. Quality control (qc) results prior to the event exhibited imprecision. Potassium qc prior to the event recovered 8. 7 mmol/l and repeated at 7. 5 mmol/l (mean was 7. 5 mmol/l). Patient samples were then run and k qc following the sample run recovered at 9. 3 and 8. 4 mmol/l. The customer recalibrated the instrument and k qc recovered at 7. 4 and 7. 6 mmol/l. The customer then ran patient samples again. A review of the customer's instrument data log indicated that the system had multiple calibration failures starting on (b)(6) 2013 through the day of the event. In addition to the erratic qc and calibration failures, on the day of the event, the instrument also flagged intermittent k results with a "sample reference drift" flag.
Patient Sequence No: 1, Text Type: D, B5
[11379052]
(b)(6). A beckman coulter field service engineer (fse) was dispatched to the customer's site. The fse evaluated the instrument and discovered a crack in the flowcell, adjacent to the potassium (k) electrode port. The fse proceeded to replace the flowcell to resolve the issue. Although it is unknown how the flowcell became cracked, the instrument provided multiple indications of the issue, with calibration failures, quality control (qc) failures, and flagged results. The customer continued to report patient results despite these indicators. Results: flowcell.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00812 |
| MDR Report Key | 3516269 |
| Report Source | 01,05,06 |
| Date Received | 2013-12-11 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-11-22 |
| Date Mfgr Received | 2013-11-22 |
| Device Manufacturer Date | 2006-12-14 |
| Date Added to Maude | 2014-03-25 |
| 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 |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 880I SYNCHRON ? ACCESS CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2013-12-11 |
| Model Number | NA |
| Catalog Number | A59102 |
| Lot Number | NA |
| ID Number | SW VERSION 4.92 |
| 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 | 2013-12-11 |