MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-22 for HEMOCHRON SIGNATURE ELITE manufactured by Accriva Diagnostics.
[126232809]
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite instrument, serial number (b)(4). Complaint number (b)(4) captures the child case for the lot number of the jact-lr cuvette used during the procedure. Instrument (b)(4) was previously reported as a child to parent complaint (b)(4), which was submitted to cdrh as mdr number 2250033-2018-00013. Accriva diagnostics has requested all data required for form 3500a. This report serves as the initial and final mdr for this case and effectively closes the complaint.
Patient Sequence No: 1, Text Type: N, H10
[126232810]
Healthcare professional reported that a hemochron signature elite and low-range act system reported inconsistent act results during a cardiovascular procedure. The patient was receiving intermittent doses of intravenous heparin with a target act range of 300 to 350 seconds. The third act result after heparin dosing was 236 seconds with elite serial number (b)(4). This was considered a lower than expected result. The same blood sample was run on a second elite, serial number (b)(4), which generated an act result of 368 seconds. The fourth and fifth blood samples generated inconsistent act results that were alternately below and above the target act range with the two elite instruments. Both hemochron signature elite and low-range act systems passed electronic and liquid qc before the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00023 |
| MDR Report Key | 7993143 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-22 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2009-02-23 |
| Date Added to Maude | 2018-10-22 |
| 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 | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582632490 |
| Manufacturer G1 | ACCRIVA DIAGNOSTICS |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON SIGNATURE ELITE |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-10-22 |
| Returned To Mfg | 2018-09-06 |
| Model Number | ELITE |
| Catalog Number | ELITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCRIVA DIAGNOSTICS |
| Manufacturer Address | 6260 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-22 |