MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-23 for HEMOCHRON JR PT CUVETTE * manufactured by Itc.
[2163945]
The international technidyne corporation (itc) cuvette used for point-of-care testing the international normal ratio (inr). The lot used first gave an inr of 2. 2. The patient presented with (myocardian infarction (mi) days later with inr of 1. 9. The lot used may have reported higher than actual result and may have contributed to the mi. ======================manufacturer response for hemochron jr. Pt cuvette j201, hemochron jr pt cuvette (per site reporter)======================a clinical escalation team has been created to review each case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2225312 |
| MDR Report Key | 2225312 |
| Date Received | 2011-08-23 |
| Date of Report | 2011-08-23 |
| Date of Event | 2011-04-14 |
| Report Date | 2011-08-23 |
| Date Reported to FDA | 2011-08-23 |
| Date Added to Maude | 2011-08-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON JR PT CUVETTE |
| Generic Name | HEMOCHRON JR. PT CUVETTE J201 |
| Product Code | GFO |
| Date Received | 2011-08-23 |
| Returned To Mfg | 2011-05-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | M0JPT079 |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITC |
| Manufacturer Address | 20 CORPORATE PLACE SOUTH PISCATAWAY NJ 08854 US 08854 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-23 |