MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-12 for SYNCHRON SYSTEMS RHEUMATOID FACTOR REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR CALIBRATOR 5 PLUS RF 469975 manufactured by Beckman Coulter, Inc..
[2625245]
Customer called to report that forty percent of the patient results generated by the immage 800 immunochemistry system were in the low positive range when using rheumatoid factor (rf) reagent lot m103174 and calibrator lot 5-plus m101436. The customer technical specialist (cts) sent customer a new lot of calibrator 5-plus, m106396. After calibrating the system with this lot on (b)(6) 2012, customer reported that 51 samples were repeated, and only four to five percent of the results were in the low positive range. This percentage of low positive results is within the expected specifications of the rf reagent. There were no reports of effects to patient treatment based on the erroneous results.
Patient Sequence No: 1, Text Type: D, B5
[9672422]
The root cause of the issue appears to be reagent-specific, relating to the calibrator lot used to generate patient results. Customer did not return the calibrator reagent lot to beckman coulter, inc. For examination. Customer has not called back to report any further issues relating to the use of the new calibrator lot. Please note that an additional medical device report was filed based on the same issue for results that were generated on (b)(6) 2012 as mdr #2050012-2012-00713 (b)(4). Other text: reagent not returned to beckman coulter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00699 |
| MDR Report Key | 2487721 |
| Report Source | 05,06 |
| Date Received | 2012-03-12 |
| Date of Report | 2012-02-15 |
| Date of Event | 2012-02-14 |
| Date Mfgr Received | 2012-02-15 |
| Device Manufacturer Date | 2011-04-19 |
| Date Added to Maude | 2012-08-27 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON SYSTEMS RHEUMATOID FACTOR REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR |
| Generic Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| Product Code | DHR |
| Date Received | 2012-03-12 |
| Model Number | CALIBRATOR 5 PLUS RF |
| Catalog Number | 469975 |
| Lot Number | M101436 |
| Device Expiration Date | 2013-01-31 |
| 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 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-12 |