MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-08-27 for IMMAGE? IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[2267037]
The customer reported that on (b)(6) 2011 imprecise rheumatoid factor (rf) results were generated on an immage immunochemistry system for one patient sample. The initial result, when tested utilizing the default dilution of 1:6, generated a result above the normal reference range. A repeat of the sample on another instrument at the same dilution level generated lower results still above the reference range. Upon multiple repeat tests on the same and two other instruments at a sample dilution factor of 1:36, the results were significantly higher. Collectively the results exceeded the precision claims of the assay. The imprecise results were not reported out of the laboratory and hence there was no death, serious injury or change to patient treatment associated or attributed to this event. Samples were serum. Instrument rf quality control (qc) results were within the customer's established specification during the timeframe of the event.
Patient Sequence No: 1, Text Type: D, B5
[9402845]
Service was not dispatched to the site for this event. The low result was due to antigen excess which can occur on samples with extremely high levels of rheumatoid factor. Beckman coulter labeling states "extremely high rf concentrations (> 6,000 iu/ml) in serum may result in an antigen excess condition producing a low rf value on the immage system. If the patient`s clinical condition does not correlate with the reported rf concentration, dilute the sample and repeat the analysis. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-04073 |
| MDR Report Key | 2225001 |
| Report Source | 01,05,06 |
| Date Received | 2011-08-27 |
| Date of Report | 2011-07-18 |
| Date of Event | 2011-07-18 |
| Date Mfgr Received | 2011-07-18 |
| Device Manufacturer Date | 2008-05-15 |
| Date Added to Maude | 2012-05-17 |
| 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 | IMMAGE? IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2011-08-27 |
| Model Number | NA |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | NA |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-27 |