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.
[114676750]
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite, serial number (b)(4), the parent case. This mdr also captures a child complaint (b)(4)for the hemochron jr act-lr (low-range) reagent cuvette used. Method codes: analysis of production records. No history of service or repairs. Results code: no findings available. Conclusion code: 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 follow-up #1 will be submitted if the device is returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[114676751]
Healthcare professional reported that a hemochron signature elite and low-range act system reported higher than expected act results during a pci procedure. The patient was receiving intravenous heparin with a target act of >250 seconds. One blood sample generated an act result that was >400 seconds, which was a higher than expected result. Another blood sample drawn 12 minutes was assayed on a second hemochron signature elite with the same lot of reagent cuvettes, which generated an act result of 180 seconds, which was an expected result. An intravenous bolus dose of heparin was administered and the procedure was successfully completed. The hemochron signature elite and low-range act system passed electronic and liquid qc before the procedure. No bleeding or medical complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00016 |
| MDR Report Key | 7701010 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-18 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2017-07-17 |
| 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 DIAGNOCTICS |
| 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 | 2018-07-24 |
| 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 | 2018-07-18 |