MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-06-24 for HEMOCHRON JR. MICROCOAGULATION ACT LOW RANGE JACT-LR manufactured by International Technidyne Corp..
[18040838]
Healthcare professional reported inconsistent patient results with the hemochron signature elite and act low range system. A (b)(6) male was receiving heparin anticoagulation via a continuous infusion plus iv bolus doses during a cardiac ablation procedure for atrial fibrillation. Three hemochron signature elite instruments were run side by side with one reagent cuvette lot of act-lr in a correlation study. The target act was greater than 300 seconds. During the procedure, act readings wore discrepant on a few occasions between the three instruments; however two values differed by more than what would be expected. Electronic and liquid quality controls passed successfully on all three instruments. The procedure was completed successfully and no patient injury or adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
[18140364]
(b)(4). The serial numbers of the hemochron signature elite instruments used during this procedure were (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68476677]
Mdr follow up #1 references itc complaint number (b)(4) and provides the results from testing reserved samples of the same reagent lot by lsr 2015-css-032. Results: precision outside of prespecified acceptance criteria at assay upper range confirms the complaint of inconsistent patient results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2015-00053 |
| MDR Report Key | 4870774 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-06-24 |
| Date of Report | 2015-06-01 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-08-20 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-06-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JON MCDERMED |
| Manufacturer Street | 8 OLSEN AVENUE |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 8582632490 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON JR. MICROCOAGULATION ACT LOW RANGE |
| Generic Name | TEST, TIME, ACTIVATED CLOTTING TIME |
| Product Code | JBP |
| Date Received | 2015-06-24 |
| Model Number | JACT-LR |
| Catalog Number | JACT-LR |
| Lot Number | M4JLR201 |
| Device Expiration Date | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-06-24 |