MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-10-22 for HEMOCHRON JR. ACT-LR HEMOCHRON JR. CUVETTE FG JAC-LR manufactured by International Technidyne Corp..
[29715321]
This mdr submitted on 10/22/2015 references (b)(4), which recorded the receipt from fda of a user-facility/importer form fda 3500a submitted by the customer. Submission of the 3500a to fda was prompted by the customer's perception (allegation) that patient results from multiple hemochron signature elite instruments across several lots of hemochron jr. Act-lr test cuvettes "are inconsistent and believed by the physicians to be inaccurate. " method: data validation. Device from controlled or non-released sample evaluated. After receipt of the medwatch, an accriva representative observed end-user technique in the cardiac cath and ep lab areas, and collect data to evaluate product performance. From more than 15 different cases, greater than 100 datasets were assessed. Results: no failure detected. Results of the data analysis strongly supported that all hemochron signature elite and act-lr test systems performed as intended and the most likely root cause of the customer's experience related to preanalytical and analytical errors during sample handling and technique. Conclusions: unable to confirm complaint. Itc has requested all data required to complete form fda 3500a.
Patient Sequence No: 1, Text Type: N, H10
[29715322]
Accriva diagnostics received a medwatch report with a complaint from a customer regarding the hemochron signature elite and act-lr test systems. The medwatch report states: "with or without anticoagulation, patient's activated clotting times (act) in the cardiac cath lab and electrophysiology labs are inconsistent and believed by the physicians to be inaccurate. This is an ongoing problem on multiple dates of service. " the customer implemented the hemochron signature elite and act-lr test systems in the fall of 2014. During instillation, accriva personnel were on-site to instruct on product storage, sample handling and instrument operation. Within a few months after the system were placed into use for patient management, the customer periodically notified accriva of concerns regarding results that did not correlate with the patient's clinical status. No adverse events were reported. These complaints were logged as (b)(4). All complaint cases involved unexpected results in the cardiac cath and/or ep labs. Both electronic qc and liquid qc passed when tested based upon the frequency stipulated in the customers quality plan. In each case, the most likely root cause was determined to be preanalytical errors or analytical errors. Corrective actions involved reeducation of the end-user that was to be conducted by laboratory staff. On-site accriva personnel also supported the laboratory's retraining process to improve the skills of the end-users.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248721-2015-00055 |
| MDR Report Key | 5180447 |
| Report Source | USER FACILITY |
| Date Received | 2015-10-22 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-09-22 |
| Date Mfgr Received | 2015-09-22 |
| Date Added to Maude | 2015-10-27 |
| 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 AVE. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 8582632490 |
| Manufacturer G1 | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Street | 8 OLSEN AVE. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEMOCHRON JR. ACT-LR |
| Generic Name | TEST, TIME, ACTIVATED CLOTTING TIME |
| Product Code | JBP |
| Date Received | 2015-10-22 |
| Model Number | HEMOCHRON JR. CUVETTE FG |
| Catalog Number | JAC-LR |
| 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 | 8 OLSEN AVE. EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-22 |