MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-27 for HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM manufactured by Accriva Diagnostics.
[131943614]
(b)(4). Method: analysis of production records. No history of service, repairs, capas or ncs. No complaints related to the one stated in the current report. Results: no findings available. Conclusion: conclusion not yet available. Accriva diagnostics has requested all data required for form 3500a. This is the initial 30-day report that precedes the instrument evaluation. Mdr 2250033-2018-00031 follow-up #1 will be submitted after the device is returned to the manufacturer and the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[131943615]
Healthcare professional reported that a hemochron signature elite and low-range act system reported lower than expected act results during an ablation treatment for atrial fibrillation. The patient received an intravenous bolus dose of heparin with an act target of 300 seconds. The first blood sample generated an act result that was as expected. The next 4 act readings were lower than the target range while additional heparin was given. A fifth blood sample was drawn and assayed on a second hemochron signature elite instrument using the same lot of hemochron act-lr cuvettes. This generated an act result >300 seconds, which was an expected result. The second signature elite instrument was used for further act testing. All act results were >300 seconds and were used for patient management. No adverse events or 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 | 2250033-2018-00031 |
| MDR Report Key | 8201757 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2018-12-27 |
| 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 | 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 | 2018-12-27 |
| Returned To Mfg | 2019-01-02 |
| Model Number | ELITE |
| Catalog Number | ELITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-12-27 |