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

Model Number	ELITE
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem Description
Follow-up #1.
Additional 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
• Common Device Name: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 8186223
• Report Number: 2250033-2018-00028
• Device Sequence Number: 13988744
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K050016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JACT-LR CUVETTE LOT E8JLR108
• Patient Age: 68 YR
• Patient Weight: 86