MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-18 for HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM manufactured by Accriva Diagnostics.
[114699873]
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite, serial number (b)(4). The lot number of the hemochron jr jact-lr (act low-range) reagent cuvette used during the procedure was c8jlr061. Method: analysis of production records. The pcb was replaced twice, in january 2012 and in january 2013. These repairs were not related to the current complaint. Results: no device problem found. The instrument passed liquid and electronic qc. Retains of lot c8jlr061 were run on (b)(4) and 2 peer instruments using heparin-spiked blood samples from 3 normal donors. Act results generated by the 3 elite instruments were not significantly different from one another. Conclusion: no problem detected. Accriva diagnostics has requested all data required for form 3500a. This report shall serve as the initial and final mdr submitted for this customer complaint.
Patient Sequence No: 1, Text Type: N, H10
[114699874]
Healthcare professional reported that a hemochron signature elite and low-range act system reported inconsistent act results during a pci and cryoablation procedure. The patient received an intravenous bolus dose of heparin with an act target range that was unspecified. The first 2 blood samples generated act results of 180 and 176 seconds, respectively, which were lower than the expected results. Another blood sample was immediately drawn and was run on a second hemochron signature elite instrument, which generated an act >400 seconds, which was an expected result. The second signature elite instrument was used for act testing until the procedure was completed. All act results were as expected and were used for patient management. No medical complications were reported. The hemochron signature elite and low-range act system passed electronic and liquid qc before the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00017 |
| MDR Report Key | 7701013 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-18 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-06-18 |
| Date Mfgr Received | 2018-06-18 |
| Device Manufacturer Date | 2011-07-12 |
| Date Added to Maude | 2018-07-18 |
| 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 MICROCOAGULATION SYSTEM |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-07-18 |
| Returned To Mfg | 2018-07-06 |
| 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 | 2018-07-18 |