MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-23 for BECKMAN COULTER HEMOSIL SILICA CLOTTING TIME PART NUMBER 20004800 manufactured by .
[1931311]
Beckman-coulter hemosil silica clotting time (part number (b)(4)). Test is used as part of testing panel for presence of lupus anticoagulant. There is variation in the lots of reagents in that some lots have much higher positivity rates (usually expect 15% of the tested population, with certain lots as high as 45%). Two positives over 10 to 12 weeks are felt to be indicative of lupus anticoagulant. Patients may receive treatment for prevention of thrombosis such as coumadin (with increased bleeding as a potential complication) or other interventions as inferior vena cava balloon. In summary, variation from lot to lot of reagents mean that there are probably significantly increased false positives with certain reagent lots.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019527 |
| MDR Report Key | 2003540 |
| Date Received | 2011-02-23 |
| Date of Report | 2011-02-14 |
| Date of Event | 2010-03-01 |
| Date Added to Maude | 2011-03-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN COULTER HEMOSIL SILICA CLOTTING TIME |
| Generic Name | SILICA CLOTTING TIME |
| Product Code | GFO |
| Date Received | 2011-02-23 |
| Catalog Number | PART NUMBER 20004800 |
| Lot Number | N0301827 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-23 |