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 UNK UNKNOWN manufactured by Itc.
[2188363]
An itc (international techdyne corporation) cuvette was used for point of care testing of inr (international normal ratio). The lot used for testing may have reported higher than actual results and resulted in administering a low dose of medication to the patient. The cuvettes were recalled by itc. The patient was admitted with cva (cardiovascular accident). ======================manufacturer response for hemochron jr. Pt cuvette j201, hemochron jr pt cuvette (per site reporter)======================itc has a clinical escalation team which is reviewing the cases thought to be related to the inr results. ======================manufacturer response for hemochron jr. Pt cuvette j201, hemochron jr pt cuvette (per site reporter)======================itc has a clinical escalation team which is reviewing the cases thought to be related to the inr result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2212802 |
| MDR Report Key | 2212802 |
| Date Received | 2011-08-12 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-02-16 |
| 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 | UNK |
| Catalog Number | UNKNOWN |
| Lot Number | M0JPT079 |
| 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 |