MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-26 for HEMOCHRON SIGNATURE ELITE manufactured by Accriva Diagnostics.
[122163884]
This mdr references accriva diagnostics' complaint (b)(4) for the hemochron signature elite instrument, serial (b)(4). Complaint (b)(4) captures the child case for the lot number of the jact+ cuvette used during the procedure. 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
[122163885]
A healthcare professional reported inconsistent act results with a hemochron signature elite and act+ whole blood microcoagulation system during an ablation procedure for an abnormal heart rhythm. The target act for this procedure was 350 seconds. The third act reading was 258 seconds, which was a lower than expected result. The same blood sample was re-tested on a different elite instrument. The act reading was 370 seconds, which was within the expected range and was used for patient management. The procedure was completed successfully and no adverse events were reported. Both electronic and liquid quality controls passed on the suspect instrument prior to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00022 |
| MDR Report Key | 7912705 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-26 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-27 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2018-09-26 |
| 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 | 2018-09-26 |
| Returned To Mfg | 2018-09-07 |
| 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 | 2018-09-26 |