MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-28 for UNICEL? DXC 600 SYNCHRON? SYSTEM A11810 manufactured by Beckman Coulter, Inc..
[2572611]
The customer reported that erroneously elevated total bilirubin (tbil) results were generated from a unicel dxc 600 synchron system for one patient's sample. This report represents the erroneously elevated tbil results generated from a unicel dxc 600 synchron system on (b)(6) 2012. The initial patient sample was a hemolyzed heel-stick sample run in a sample cup. The erroneous, initial tbil result was reported outside of the laboratory and the patient was transported and admitted to a hospital for follow-up treatment based upon the tbil results. Beckman coulter inc. Assessment of customer supplied patient data indicated that the patient was redrawn at the hospital via venipuncture and retested on an alternate instrument. The results were lower and regarded as valid. The patient's history and current laboratory results did not note any patient abnormalities, and the redrawn sample's results were below the threshold for phototherapy. The patient was not treated and was discharged. No other patient samples were affected.
Patient Sequence No: 1, Text Type: D, B5
[9724481]
Service was not dispatched to the site for this event as it was believed to be sample related. Beckman coulter inc. Assessment of customer supplied instrument/chemistry performance data indicated that tbil calibration and quality control results had been acceptable. No customer maintenance was needed, and no maintenance was performed specifically for this issue. Beckman coulter inc. Customer information sheets indicate red blood cell hemolysate as a source of interference; however the specific patient sample involved in this event was not interference tested and hence this cannot be confirmed for this event. The beckman coulter inc. Representative advised the customer to reject all hemolyzed neonatal heel stick samples for tbil. While the cause may have been sample-specific interference, a definitive root cause for this event has not been determined to date. Associated mdrs: 2050012-2012-00774, 2050012-2012-00775.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00774 |
| MDR Report Key | 2508239 |
| Report Source | 05,06 |
| Date Received | 2012-03-28 |
| Date of Report | 2012-03-05 |
| Date of Event | 2012-03-02 |
| Date Mfgr Received | 2012-03-05 |
| Device Manufacturer Date | 2010-01-11 |
| Date Added to Maude | 2012-03-29 |
| 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 | 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, 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | JFM |
| Date Received | 2012-03-28 |
| Model Number | NA |
| Catalog Number | A11810 |
| Lot Number | NA |
| ID 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, INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-03-28 |