MAUDE Adverse Event Report: ARKRAY FACTORY, INC. AUTION HYBRID AU-4050; URINE ANALYZER

Model Number	14601
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Arkray's investigation determined the cause to be software related, not hardware.A scar was issued to the software developer (sysmex) for corrective action.Sysmex identified that this issue was caused by an incorrect shut down by users after analyzing the software and the log of the instrument.Sysmex is working on a software update to prevent this issue even if the user error occurs.When we initially received the complaint, it wasn't judged to be serious, however, our judgment for seriousness was changed by the subsequent investigation result and additional information.Accordingly, we have decided to file an mdr.
Event or Problem Description
Patient had his demographics assigned to another patient's sample results.Samples were run without query to the lis meaning no order was received from the lis and therefore no orders with patient demographics.On (b)(6) 2018 it was found that three samples without query and therefore orders still had demographics associated with them on both the analyzer printout and the lis transmission and in all three cases those demographics were for the incorrect patients (three patients listed above).In none of these cases were the patients misdiagnosed or mistreated.The patient results were correctly tied to the correct patients at the lis because the lis already has the correct demographic information.Demographic information sent by the analyzer with the results is ignored by the lis.

• Brand Name: AUTION HYBRID AU-4050
• Common Device Name: URINE ANALYZER
• Manufacturer (Section D): ARKRAY FACTORY, INC.; 1480 koji konan-cho; koka shiga, 520-3306, ; JA
• MDR Report Key: 8326305
• Report Number: 9611444-2019-00002
• Device Sequence Number: 1954535
• Product Code: KQO
• UDI-Device Identifier: 00015482146030
• UDI-Public: (01)00015482146030
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2019

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: 14601
• Device Catalogue Number: 14601
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR