MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON JR APTT CUVETTES; SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Model Number	J103
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: actual device not evaluated.Photographs of the device named in this complaint were supplied by the distributor for china.Process evaluation was performed.Results: no results available since no evaluation performed.Conclusions: device not returned.Accriva diagnostics has requested all data required for form 3500a.
Event or Problem Description
Accriva's distributor for (b)(4) reported a complaint from a customer concerning a hemochron signature elite and hemochron jr aptt microcoagulation system.The end user was monitoring aptt readings every two hours in a patient receiving a continuous intravenous infusion of heparin.The baseline aptt reading was 30 seconds, which increased to 60 seconds during drug administration.An aptt reading was done and gave a result of 90 seconds.The aptt was again repeated and gave a result of 64 seconds, which was an expected therapeutic value.The reading of 90 seconds was dismissed as being erroneous and no adjustment to the heparin dose was made.The hemochron signature elite and hemochron jr aptt microcoagulation system successfully passed both levels of liquid quality control and electronic quality control.No adverse events, bleeding or other medical issues were reported.

• Brand Name: HEMOCHRON JR APTT CUVETTES
• 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: 6726520
• Report Number: 2250033-2017-00002
• Device Sequence Number: 13763856
• Product Code: JPA
• UDI-Device Identifier: 10711234103012
• UDI-Public: 10711234103012
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K940432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/19/2017

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 Expiration Date: 07/31/2017
• Device Model Number: J103
• Device Catalogue Number: J103
• Device Lot Number: G6JCA043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 63