MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-22 for THROMBOPLASTIN C PLUS REAGENT * manufactured by Dade-behring.
[538230]
A physician contacted the diagnostic lab manager with a concern about protime and inr(international normalized ratio) results. He had noticed that over a period of one month the increase in the inr of his "normally stable" patients. Two of his patient's samples that had already been drawn were sent to the hospital's main lab for repeat verification of the inr on a different instrument. Results showed a discrepancy between the results. Documentation on implementing of the reagent lot were all correct. They contacted the technical support at the manufacturer and were told that "they had heard about problems with the lot in question. " from that time on all protime specimens were to be sent to the main hospital lab. Contact with the manufacturer was made and arrangements were made to ship a different reagent overnight- innovin with a isi of 1. 0. New comparison studies of the reagent were expected to take about a week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 771022 |
| MDR Report Key | 771022 |
| Date Received | 2006-09-22 |
| Date of Report | 2006-09-22 |
| Date of Event | 2006-09-05 |
| Report Date | 2006-09-22 |
| Date Reported to FDA | 2006-09-22 |
| Date Added to Maude | 2006-10-20 |
| 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 | 3 |
| 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 | THROMBOPLASTIN C PLUS REAGENT |
| Generic Name | REAGENT, THROMBOPLASTIN C PLUS |
| Product Code | GGO |
| Date Received | 2006-09-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 537014 |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 758822 |
| Manufacturer | DADE-BEHRING |
| Manufacturer Address | PO BOX 6101 GLASCOW BLDG. 500 NEWARK DE 197146101 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-22 | |
| 2 | 0 | 2006-09-22 |