MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2012-01-19 for IMMAGE IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[134263764]
Service was not dispatched for this incident. Root cause is not known but appears to be reagent related.
Patient Sequence No: 1, Text Type: N, H10
[134263765]
The customer reported that false positive rheumatoid factor (rf) patient results, associated with the use of a specific immage immunochemistry system rheumatoid factor (rf) reagent lot, were generated on an immage immunochemistry system for twelve patients. No patient results were provided by the customer so it is not possible to confirm the number of patients involved, assess the actual patient results generated by the instrument and rf reagent, or confirm the date of occurrence. The rf reagent lot number in use on the instrument during time of this event was m101865. The initially positive rf results were repeated by an alternate reference laboratory which reported the results as negative. The initial erroneous rf results were not reported out of the laboratory hence there were no deaths, serious injuries or change to patient treatment associated or attributed to this event. No issues with other chemistries were reported. No patient specific information was provided by the customer. No sample issues were noted. Chemistry instrument quality controls were recovering acceptably during the timeframe of the event. No system errors were noted. No additional sample handling/collection information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2012-00157 |
| MDR Report Key | 2422499 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2012-01-19 |
| Date of Report | 2011-12-28 |
| Date of Event | 2011-12-26 |
| Date Mfgr Received | 2011-12-28 |
| Device Manufacturer Date | 2006-01-12 |
| Date Added to Maude | 2012-01-19 |
| 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 | 3 |
| Event Location | 3 |
| 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 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMMAGE IMMUNOCHEMISTRY SYSTEM |
| Generic Name | EPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2012-01-19 |
| Model Number | NA |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-01-19 |