MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-24 for UNICEL? DXC 600 SYNCHRON? CLINICAL SYSTEM A10405 manufactured by Beckman Coulter, Inc..
[19271197]
A customer contacted beckman coulter inc. (bci) in regards to erroneously low triglyceride (tg) results generated by unicel dxc 600 synchron clinical system for an unknown number of patients between (b)(6) 2010 and (b)(6) 2011. The results were reported out of the laboratory. The tests performed on (b)(6) 2011 were repeated and the results are shown in the attached file. Eight (8) patients, among those tested between (b)(6) 2010 and (b)(6) 2011, were identified by physicians and requested to return for re-tests. Repeat tests have not been performed to date. There was no effect to the patients tested on (b)(6) 2011. The effect to the rest of the patients is unknown.
Patient Sequence No: 1, Text Type: D, B5
[19423630]
On (b)(6) 2010, the customer changed the tg setpoint to 217. 3mg/dl, which was the correct setpoint. On (b)(6) 2010, the customer ran a calibration with the correct tg setpoint, but failed due to back-to-back error (imprecision). Later on the day, the customer ran a calibration again and was successful. The customer indicates they did not change the setpoint or reload the calibrator diskette between the two calibrations on (b)(6) 2010. On (b)(6) 2011, the customer noticed the wrong setpoint had been in use since (b)(6) 2010, and changed it back to 217. 3 mg/dl. The customer then reran all patients from (b)(6) 2011 and reviewed patients run between (b)(6) 2010 and (b)(6) 2011. The customer notified physicians of all patients run between (b)(6) 2011 and (b)(6) 2011 that if the issue was of concern, the patients should be redrawn for retesting. Of those patients, the physicians identified 8 patients to return for redraw and retest. As of this time, none of the 8 patients has returned for retesting. The customer will retain information for bci on those 8 patients if they return. It is assumed that the patients which were not identified for redraw would not have been impacted by the difference in tg results due to this issue. Service was not dispatched for this event. The root cause for this event was incorrect calibrator setpoint for tg. However, the root cause for the incorrect setpoint being in the system is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-01892 |
| MDR Report Key | 2101393 |
| Report Source | 05,06 |
| Date Received | 2011-05-24 |
| Date of Report | 2011-03-30 |
| Date of Event | 2010-12-27 |
| Date Mfgr Received | 2011-03-30 |
| Device Manufacturer Date | 2005-09-28 |
| Date Added to Maude | 2011-07-21 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600 SYNCHRON? CLINICAL SYSTEM |
| Generic Name | CLINICAL CHEMSTRY ANALYZER |
| Product Code | JGY |
| Date Received | 2011-05-24 |
| Model Number | DXC 600 |
| Catalog Number | A10405 |
| Lot Number | NA |
| ID Number | S.V 4.9.02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-24 |