MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-03-10 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS. RF HRS. FR / HRFTCA510 manufactured by International Technidyne Corp..
[1332512]
Healthcare professional reports inconsistent patient results. Hemochron response system consistently giving act results greater than 1500 seconds, on multiple non- heparinized patients. Healthcare professional did not indicate number of patients involved. No report of adverse event, serious injury, or intervention reported. This event occurred in a foreign country.
Patient Sequence No: 1, Text Type: D, B5
[8448140]
(b)(4). Manufacturer's evaluation currently in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2010-00023 |
| MDR Report Key | 1628963 |
| Report Source | 08 |
| Date Received | 2010-03-10 |
| Date of Report | 2010-03-09 |
| Date Mfgr Received | 2010-02-09 |
| Date Added to Maude | 2010-08-03 |
| 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 | LAWRENCE PICCIANO |
| Manufacturer Street | 8 OLSEN AVE. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 7325485700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON RESPONSE COAGULATION SYSTEM |
| Generic Name | RESPONSE INST / ACT TUBE ASSAY |
| Product Code | KQG |
| Date Received | 2010-03-10 |
| Returned To Mfg | 2010-03-04 |
| Model Number | HRS. RF |
| Catalog Number | HRS. FR / HRFTCA510 |
| Lot Number | C9FTE061A |
| Device Expiration Date | 2012-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-10 |