MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-12 for HEMOCHRON JR PT CUVETTE * manufactured by Itc.
[20952218]
An itc (international techdyne corporation) cuvette was used for point of care testing of inr. The lot number used gave an inr of 2. 5 which may have reported higher than actual result. The inr on at a later day was 1. 5. The cuvette was recalled by itc. ======================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. ======================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 | 2212801 |
| MDR Report Key | 2212801 |
| Date Received | 2011-08-12 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-01-17 |
| Report Date | 2011-08-12 |
| Date Reported to FDA | 2011-08-12 |
| Date Added to Maude | 2011-08-16 |
| 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 | 3 |
| 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 | 2011-08-12 |
| Returned To Mfg | 2011-05-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | G0JPT075 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITC |
| Manufacturer Address | 6-8 OLSEN AVE. EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-12 |