MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-27 for SYNCHRON LX CLINICAL CHEMISTRY TEST SYSTEM CALIBRATOR 1 468405 manufactured by Beckman Coulter, Inc..
[2255722]
The customer indicated that on (b)(6) 2011 an erroneous, elevated complement 4 (c4) result for one patient was generated in conjunction with a specific synchron lx clinical chemistry test system calibrator 1 lot (lot m005558). Upon repeat, the c4 result was higher. The repeat result was reported outside the laboratory because it was not regarded as clinically significantly different from the initial result. The patient was not treated based on the reported value. There was no death, serious injury or modification to patient treatment associated or attributed to this event. Instrument c4 and transferrin quality control results also trended high with the use of the new clinical chemistry test system calibrator lot. The customer did not indicate that any erroneous transferrin patient results were generated.
Patient Sequence No: 1, Text Type: D, B5
[9348597]
Service was not dispatched to the site as it was believed to be reagent related. The root cause of this event appears to be related to the calibrator lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05584 |
| MDR Report Key | 2266449 |
| Report Source | 05,06 |
| Date Received | 2011-09-27 |
| Date of Report | 2011-08-28 |
| Date of Event | 2011-08-28 |
| Date Mfgr Received | 2011-08-28 |
| Device Manufacturer Date | 2011-04-27 |
| Date Added to Maude | 2012-06-14 |
| 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 NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON LX CLINICAL CHEMISTRY TEST SYSTEM CALIBRATOR 1 |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | DEW |
| Date Received | 2011-09-27 |
| Model Number | NA |
| Catalog Number | 468405 |
| Lot Number | M005558 |
| ID Number | NA |
| Device Expiration Date | 2012-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-09-27 |