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

Model Number ELITE-INT

Device Problem Non Reproducible Results (4029)

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

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite international instrument, serial number (b)(4).Accriva diagnostics' complaint number (b)(4) referenced the child case capturing the disposable hemochron jr.Act-lr device (lot number j7jlr194) that was used during the procedure.Method: testing of actual/suspected device.Dhr review showed no ncs, capa, or a relevant history of repair.Results: no device problem found.The instrument was tested to heparin sensitivty procedure qc-188 using 2 lots of act-lr cuvettes and side by side with 3 other control instruments.The device performed within specifications.Conclusion: no problem detected.This mdr serves as the initial and final report for the hemochron signature elite and act-lr microcoagulation system, instrument serial number (b)(4), lot j7jlr194.The complaint was not confirmed.

Event Description

Healthcare professional working in a hospital in (b)(6) reported that two hemochron signature elite and act low-range assay systems reported inconsistent act results when the meters were run side-to-side during a pci and stent placement procedure.The patient was receiving intermittent doses of intravenous heparin with a target act range of 300-350 seconds.The same lot number of hemochron jr act-lr cuvettes (j7jlr194) was used on both meters throughout the procedure.One blood sample generated a pair of act results that differed significantly from one another.The act result assayed on the elite named in this complaint ((b)(4)) was 254 seconds, which was lower than the target act.The act result reported on the second elite ((b)(4)) was 321 seconds, which was an expected result.The act result of 321 seconds was used for patient management.No bleeding, thrombosis or other medical complications were reported.Both hemochron signature elite instruments passed electronic qc before the procedure.Act-lr readings with liquid qc (normal and abnormal levels) were within their acceptable ranges when run on both instruments.The distributor asked the customer to return the device for evaluation, however, the customer declined to do so as of (b)(6) 2018, when accriva closed the initial complaint.The complaint case was reopened on (b)(6) 2018 when the customer decided to return the instrument to accriva for evaluation because of recurrent instances of reporting inconsistent act results.

• Brand Name: HEMOCHRON SIGNATURE ELITE INTERNATIONAL
• Type of Device: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• Manufacturer (Section G): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• Manufacturer Contact: jon mcdermed ; 6260 sequence drive; san diego, CA 92121 ; 8582632490
• MDR Report Key: 7993153
• MDR Text Key: 126246717
• Report Number: 2250033-2018-00024
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ELITE-INT
• Device Catalogue Number: ELITE-INT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 70