MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-03-20 for HEMOSIL VON WILLEBRAND FACTOR ACTIVITY 0020004700 manufactured by Instrumentation Laboratory Co..
[2573674]
Customer complaint received indicating a normal vwf activity and vwf antigen results (high ratio) could have missed a type 2 vwd. Specifically, pt sample had a vwf activity, vwf antigen and multimer analysis run. The vwf activity gave a result of 99% and the vwf antigen gave a result of 71%. The ratio was 1. 39, which was reported out. The multimer analysis indicated a type 2 pattern and a ristocetin was ordered. The ristocetin test recovered 45%.
Patient Sequence No: 1, Text Type: D, B5
[9705196]
Attach is a synopsis of the testing to date and the investigation that is on-going at the contract mfr, biokit. A follow-up report will be filed as soon as the conclusion and risk assessment are finalized. Conclusion: a review of the difference between columns b and c as well as the ratios in columns d and e indicates that there are some samples for which incubation with bovine igg caused the vwf activity result and thus the ratio to decrease, which suggests the presence of habia in these pt samples. Status: biokit is currently performing further investigation of the reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217183-2012-00002 |
| MDR Report Key | 2513261 |
| Report Source | 05,08 |
| Date Received | 2012-03-20 |
| Date of Report | 2012-03-20 |
| Date of Event | 2011-11-14 |
| Date Mfgr Received | 2011-12-06 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-08-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAROL MARBLE |
| Manufacturer Street | 180 HARTWELL ROAD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7818614467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOSIL VON WILLEBRAND FACTOR ACTIVITY |
| Generic Name | FACTOR DEFICIENCY TEST |
| Product Code | GGP |
| Date Received | 2012-03-20 |
| Model Number | NA |
| Catalog Number | 0020004700 |
| Lot Number | B11655 |
| ID Number | NA |
| Device Expiration Date | 2012-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTRUMENTATION LABORATORY CO. |
| Manufacturer Address | 180 HARTWELL ROAD BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-20 |