MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM; SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Model Number ELITE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Event Description

Follow-up #1.

Manufacturer Narrative

Mdr number 2250033-2018-00028 follow-up #1 provides the results of the instrument and disposable evaluation for the hemochron signature elite instrument, serial number (b)(6), the parent case, and child case 181287 capturing jact-lr cuvette lot e8jlr108.Method code: 10 actual device was evaluated per lsr 2018-css-040.Results code: 213 liquid qc was tested on se13866 and two comparator signature elites.Results were within 10% of the mean and met precision specifications.Electronic qc was tested at two levels and passed.Replicate measurments of donor whole blood were assayed neat and after spiked with two concentrations of heparin.Results generated from retains of jact-lr lot e8jlr108 showed a %cvs of <10%, which met the pre-specified requirement for precision.Conclusions code: 67 no problem detected.This submission provides closure to this complaint and serves as the final mdr.

• Brand Name: HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM
• Type of Device: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 8186223
• MDR Text Key: 131929852
• Report Number: 2250033-2018-00028
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (y/n): N
• PMA/PMN Number: K050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ELITE
• Device Catalogue Number: ELITE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JACT-LR CUVETTE LOT E8JLR108
• Patient Age: 68 YR
• Patient Weight: 86