MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-20 for HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM manufactured by Accriva Diagnostics.
[131929852]
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 lot of hemochron act-lr (low-range) reagent cuvettes used during the procedure. Accriva diagnostics has requested all data required for form 3500a. This is the initial 30-day report that precedes the instrument evaluation. 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
[131929853]
Healthcare professional reported that a hemochron signature elite and low-range act system reported inconsistent patient results during a pci procedure and coronary artery stent placement. The patient was receiving intravenous heparin with a target act of >250 seconds. The second and fourth blood samples generated act results of 336 and 343 seconds, respectively, which were as expected. However, the third and fifth blood samples generated act results of 239 and 287 seconds, respectively, which were lower than the targer act of >250 seconds. A review of the sample collection, sample waste, sample dispensing and test procedures performed at the healthcare facility were in conformance with the jact-lr instructions for use and the hemochron signature elite operator manual. No other anticoagulants (antiplatelet agents, low molecular weight heparins or direct thrombin inhibitors) were used during the pci and stent placement. Electronic and liquid qc passed prior to the procedure. No bleeding or medical complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00028 |
| MDR Report Key | 8186223 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-20 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-12-20 |
| 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 | 2018-12-20 |
| Returned To Mfg | 2019-01-04 |
| 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 | 2018-12-20 |