MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2012-05-24 for HEMOSIL VON WILLEBRAND FACTOR ACTIVITY 0020004700 manufactured by Instrumentation Laboratory Co..
[2784779]
The customer, who uses a sta analyzer, reported that "for almost the past 3 weeks now, we have been troubleshooting the ristocetin cofactor assay using the hemosil vwf reagent lot b11498, exp 7/31/2012. According to the customer, there appears to be a shift of some sort with the reagent. The normal range for the normal control is 67-91%, but the customer is recovering much higher results. Also they are recovering much higher results for other known assay materials.
Patient Sequence No: 1, Text Type: D, B5
[9884916]
This product lot number, b11498, is under recall action and is on file with the fda as a class ii action (reference z-1519-2012). The customer had not received the recall notification at the time of the incident and has since received the notification and followed the necessary actions. Per the customer, no patient treatment or adverse events were involved with this complaint. Further, il makes no claim for performance of this reagent on a non-il analyzer which the customer was using.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217183-2012-00007 |
| MDR Report Key | 2593701 |
| Report Source | 06,08 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-05-24 |
| Date of Event | 2012-03-23 |
| Date Mfgr Received | 2012-04-12 |
| Device Manufacturer Date | 2011-02-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2012-05-24 |
| Model Number | NA |
| Catalog Number | 0020004700 |
| Lot Number | B11498 |
| Device Expiration Date | 2012-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-05-24 |