MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-10 for SYNCHRON CALIBRATOR 1 468405 manufactured by Beckman Coulter Inc..
[2015014]
A customer reported to beckman coulter inc. (bci) obtaining transferrin results higher with a new lot of calibrator for two (2) samples. Results were not reported out of the lab. No effect to patients was reported.
Patient Sequence No: 1, Text Type: D, B5
[9133229]
Customer did not provide sample information. Customer indicated qc shifted higher for transferrin with this lot of calibrator. Customer did not provide calibration data. No other chemistry issues or system errors were noted. A clear root cause has not been determined at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02172 |
| MDR Report Key | 2120651 |
| Report Source | 06 |
| Date Received | 2011-06-10 |
| Date of Report | 2011-05-12 |
| Date of Event | 2011-05-11 |
| Date Mfgr Received | 2011-05-12 |
| Device Manufacturer Date | 2011-04-27 |
| Date Added to Maude | 2012-02-22 |
| 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. 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 BOULEVARD |
| 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 CALIBRATOR 1 |
| Generic Name | MULTI-ANALYTE CALIBRATOR |
| Product Code | DEW |
| Date Received | 2011-06-10 |
| Model Number | NA |
| Catalog Number | 468405 |
| Lot Number | M005558 |
| ID Number | NA |
| Device Expiration Date | 2012-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-10 |