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.
[114676260]
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
[114676261]
Healthcare professional reported that a hemochron signature elite and low-range act system reported higher than expected act results during a pci procedure and coronary stent placement. The patient was receiving intravenous heparin with a target act of >250 seconds. One blood sample generated an act result that was 173 seconds, which was a lower than expected result. A bolus dose of heparin was given and another blood sample drawn 9 minutes later generated an act result of 344 seconds, which was a higher than expected result. The heparin infusion was discontinued and a repeat blood sample drawn 38 minutes later was 161 seconds. This result was used for patient management and heparin administration was resumed. The hemochron signature elite and low-range act system passed electronic and liquid qc before the procedure. No bleeding was reported during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00018 |
| MDR Report Key | 7701019 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-18 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-06-12 |
| 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 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 | 2018-07-24 |
| 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 |