MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-20 for SYNCHRON? SYSTEMS DIRECT LDL CHOLESTEROL REAGENT 969706 manufactured by Beckman Coulter Inc..
[2501148]
A customer contacted beckman coulter inc. (bec) regarding false positive ldld (cholesterol) results generated by the unicel dxc 800 pro clinical chemistry analyzer. Per customer, the technician put a ldld cartridge on, did not run qc and tests were run on the instrument and results were reported out. The physician questioned the high ldld results. The customer investigated and discovered that instrument was running tests from the cartridge that was just loaded and qc was not run on it. Product labeling instructs to run qc after loading a new cartridge. The customer removed that cartridge and repeated results with a different cartridge and results were acceptable. An amended report was issued. There was no affect to patient with regard to this event.
Patient Sequence No: 1, Text Type: D, B5
[9574725]
No sample information was provided. Per customer, no sample issues were noted. Qc data faxed by customer showed several >4sd fliers a day before the event. No issues with other chemistries or system errors were noted. A clear root cause for the event is unknown but appeared to be a reagent issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-08506 |
| MDR Report Key | 2383234 |
| Report Source | 05,06 |
| Date Received | 2011-12-20 |
| Date of Report | 2011-11-29 |
| Date of Event | 2011-11-29 |
| Date Mfgr Received | 2011-11-29 |
| Device Manufacturer Date | 2006-03-06 |
| Date Added to Maude | 2012-07-25 |
| 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 | 0 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? SYSTEMS DIRECT LDL CHOLESTEROL REAGENT |
| Generic Name | LIPOPROTEIN TEST SYSTEM |
| Product Code | MRR |
| Date Received | 2011-12-20 |
| Model Number | NA |
| Catalog Number | 969706 |
| Lot Number | NOT PROVIDED |
| ID Number | DXC 800 PRO 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 INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-20 |