MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-16 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS.110 HRS.110/HRFTCA510 manufactured by International Technidyne Corp..
[1329981]
Health professional reports receiving lower than expected act results using a hemochron response system while performing an unspecified procedure. After receiving 2 consecutive lower than expected act results, professional tests side by side with another hemochron response system. At 11:24, act result 442 using hemochron response system vs act result 278 using another hemochron response system. At 11:30, act result 325 using hemochron response system vs act result 411 using another hemochron response system. At 11:58, act result >1500 using hemochron response system vs act result 143 using another hemochron response system. Professional started a new lot of act tubes as a result of the elevated act result. At 12:10, using new lot of act tubes, act result 219 using hemochron response system vs act result 220 using another hemochron response system.
Patient Sequence No: 1, Text Type: D, B5
[8420902]
(b)(4). Mfr evaluation currently in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2009-00576 |
| MDR Report Key | 1512345 |
| Report Source | 05,06 |
| Date Received | 2009-10-16 |
| Date of Report | 2009-10-16 |
| Date of Event | 2009-09-17 |
| Date Mfgr Received | 2009-09-17 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2010-06-30 |
| 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 | 2009-10-16 |
| Returned To Mfg | 2009-10-15 |
| Model Number | HRS.110 |
| Catalog Number | HRS.110/HRFTCA510 |
| Lot Number | A9FTE016A |
| Device Expiration Date | 2012-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2009-10-16 |