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

Model Number ELITEINT

Device Problem Low Test Results (2458)

Patient Problem Missing Value Reason (3192)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Actual device not evaluated.Process evaluation performed.No ncs, irs capas or instrument repairs recorded in the dhr.No results available since no evaluation performed.Device not returned.Accriva diagnostics has requested all data required for form 3500a.An instrument evaluation is anticipated.Results of the evaluation will be submitted as mdr 2250033-2018-00010 follow-up #1.

Event Description

Distributor of accriva products for (b)(4) reported a lower than expected act result with a hemochron signature elite and act+ microcoagulation system.During an unspecified procedure in the cath lab, the patient reportedly received an unspecified bolus dose of heparin with a target act of 300 seconds.The patient's initials, age, gender and weight were not specified.The type of procedure, act draw time(s) and results, concomitant medications and clinical circumstances of the case are unknown at the time of this report; however, this information has been requested.

Event Description

Follow-up #1.

Manufacturer Narrative

Mdr 2250033-2018-00010 follow-up #1 provides the results of the instrument evaluation for the hemochron signature elite instrument, serial number (b)(4) named in accriva diagnostics' complaint number (b)(4).This follow-up mdr also provides the date of manufacture on this instrument.Additional information to device mfr date: 10/12/2016.Method code: 10: testing of actual/suspected device.Results code: 213: no device problem found.Donor whole blood was assayed and results were found to be within specification.Electronic qc passed as well.Conclusion code: 67: no problem detected.This follow-up mdr documents closure of this complaint.No additional reports are required.

Event Description

Follow-up #2.

Manufacturer Narrative

D4: catalog number: eliteint.Model number: eliteint.Udi: (b)(4).

• 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: 7470847
• MDR Text Key: 106873485
• Report Number: 2250033-2018-00010
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 0110711234510018
• Combination Product (y/n): N
• PMA/PMN Number: K050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ELITEINT
• Device Catalogue Number: ELITEINT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1