MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-30 for FREE LITE HUMAN LAMBDA FREE KIT-OLYMPUS AU SERIES * manufactured by The Binding Site Inc..
[20925242]
Upon receipt of a new lot of reagent (the binding site ltd. , san diego, ca, lot #257764a)for serum free light chain lambda, our method validation noted a shift between lots >40%. Free lambda chain results displayed clinically significant differences in 4 out of 5 patients as well as kappa/lambda ratio changes in 3 out of 5 patients. ====================== manufacturer response for specific lot # of reagent, free lite human lambda free kit-olympus au series======================in an attempt to resolve the problem, the discrepant samples were also assayed by the manufacturer who reported the same discrepancies, but offered no solution to the problem. We suggested that the manufacturer inform other reagent users of the problem. Manufacturer indicated that the problem was unique to our lab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1209263 |
| MDR Report Key | 1209263 |
| Date Received | 2008-09-30 |
| Date of Report | 2008-09-30 |
| Date of Event | 2008-09-10 |
| Report Date | 2008-09-30 |
| Date Reported to FDA | 2008-09-30 |
| Date Added to Maude | 2008-10-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREE LITE HUMAN LAMBDA FREE KIT-OLYMPUS AU SERIES |
| Generic Name | REAGENT, MONOCLONAL |
| Product Code | DEH |
| Date Received | 2008-09-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | LOT# 257764A |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1254699 |
| Manufacturer | THE BINDING SITE INC. |
| Manufacturer Address | 5889 OBERLIN DRIVE SUITE 101 SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-30 |