MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-24 for SUPER SERUM CLOT PROMOTING REAGENT BAXTER SCIENTIFIC 4297 manufactured by International Technidyne.
[17181]
Reagent is added to heparin 1220 plasma to remove fibrinogen from blood samples and allow testing on blood samples where serum is a requirement. The product claims to accomplish this within 5 minutes after addition; however rptr has had samples where the clotting is incomplete over 1 hr after reagent has been added. Partial digestion of fibrinogen can allow the sample to continue to clot during analysis; this could cause either a falsely elevated or decreased value and lead to incorrect diagnosis or treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006537 |
| MDR Report Key | 23584 |
| Date Received | 1995-07-24 |
| Date of Report | 1995-07-19 |
| Date Added to Maude | 1995-07-24 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER SERUM CLOT PROMOTING REAGENT |
| Generic Name | CLOT PROMOTING REAGENT |
| Product Code | KQG |
| Date Received | 1995-07-24 |
| Catalog Number | BAXTER SCIENTIFIC 4297 |
| Lot Number | 2205 2 |
| Device Expiration Date | 1996-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 23881 |
| Manufacturer | INTERNATIONAL TECHNIDYNE |
| Manufacturer Address | 23 NEVSKY ST EDISON NJ 08820 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-07-24 |