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

Model Number 14601

Device Problem Patient Data Problem (3197)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Arkray's investigation determined the cause to be software related, not hardware.A scar was issued to the software developer ((b)(4)) for corrective action.((b)(4)) identified that this issue was caused by an incorrect shut down by users after analyzing the software and the log of the instrument.((b)(4)) 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.Original incident was reported in (b)(6) (9611444-2019-00002), however since filing, we received clarification there were two additional patients involved.Filing 2 of 2 additional patients with this mdr.

Event Description

Patient had her 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
• Type of Device: URINE ANALYZER
• Manufacturer (Section D): ARKRAY FACTORY, INC.; 1480 koji konan-cho; koka shiga, 520-3306, ; JA
• Manufacturer (Section G): ARKRAY FACTORY, INC.; 1480 koji konan-cho; koka shiga, 520-3306, ; JA
• Manufacturer Contact: tom speikers ; 5182 w 76th street; minneapolis, MN 55439 ; 9526463168
• MDR Report Key: 8466042
• MDR Text Key: 146081613
• Report Number: 9611444-2019-00004
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00015482146030
• UDI-Public: (01)00015482146030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 14601
• Device Catalogue Number: 14601
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR