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	06/18/2018
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 lot number of the hemochron jr jact-lr (act low-range) reagent cuvette used during the procedure was c8jlr061.Method: analysis of production records.The pcb was replaced twice, in january 2012 and in january 2013.These repairs were not related to the current complaint.Results: no device problem found.The instrument passed liquid and electronic qc.Retains of lot c8jlr061 were run on (b)(4) and 2 peer instruments using heparin-spiked blood samples from 3 normal donors.Act results generated by the 3 elite instruments were not significantly different from one another.Conclusion: no problem detected.Accriva diagnostics has requested all data required for form 3500a.This report shall serve as the initial and final mdr submitted for this customer complaint.
Event or Problem Description
Healthcare professional reported that a hemochron signature elite and low-range act system reported inconsistent act results during a pci and cryoablation procedure.The patient received an intravenous bolus dose of heparin with an act target range that was unspecified.The first 2 blood samples generated act results of 180 and 176 seconds, respectively, which were lower than the expected results.Another blood sample was immediately drawn and was run on a second hemochron signature elite instrument, which generated an act >400 seconds, which was an expected result.The second signature elite instrument was used for act testing until the procedure was completed.All act results were as expected and were used for patient management.No medical complications were reported.The hemochron signature elite and low-range act system passed electronic and liquid qc before the procedure.

• 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: 7701013
• Report Number: 2250033-2018-00017
• Device Sequence Number: 996035
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 06/18/2018

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: 07/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 101