MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-26 for HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM manufactured by Accriva Diagnostics.
[131942244]
(b)(4). Method: analysis of production records. No ncs or capas related to the instrument. Main pcb replaced in july 2015 for an unrelated complaint. 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 2250033-2018-00029 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
[131942245]
Healthcare professional reported that a hemochron signature elite and low-range act system reported inconsistent patient results. The patient suffered an acute coronary event, was successfully resuscitated and was started on intravenous heparin during an emergency pci and stent placement. The target act was >200 seconds. The first 2 blood samples generated outside reportable range (oor) high errors, the second of which was considered suspicious. A second dose of intravenous heparin was given and the act result was reported as 164 seconds, which lower than expected. A back-up hemochron signature elite was utilized for the remainder of the procedure using the same lot of low-range act cuvettes. Two blood samples were subsequently drawn for act measurements and both reported values were >200 seconds as was expected. Electronic and liquid qc passed prior to the procedure. No bleeding or other medical complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00029 |
| MDR Report Key | 8198241 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-26 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2019-01-14 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2018-12-26 |
| 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 MICROCOAGULATION SYSTEM |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-12-26 |
| Returned To Mfg | 2018-12-20 |
| 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 | 2018-12-26 |