MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed in response to a complaint of error 4033 sorter x axis home overrun for aia-2000.It is not known whether the device was being used for treatment or diagnosis at the time of the complaint.This is a level 2 investigation due to a delay in reporting of alpha fetal protein (afp) however there is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.By phone, technical support had the customer inspect for any dropped/loose reagent cups, verify that all cup trays are seated correctly and performed an all set home command but the reported error persisted.Field service was dispatched.At the customer site, field service performed a visual inspection of the sorter which found sorter x-axis assembly was difficult to move due to lack of lubrication on the x-axis linear rail.Field service cleaned and lubricated the sorter x-axis assembly linear guide bearings, axis linear rails and cleaned the x-axis drive motor gear and rack.Several cups were removed from inside the sorter and the worn sorter pickup suction pad was replaced.Verified all sorter cup and tip alignments and observed normal sorter movements after lubrication.Ran sorter corner cup macro to test operation without errors.Daily check and qc were run and meet specs.System is operating as expected this indicates a lack of lubrication of the sorter and fatigue problems with the suction pads all due to component failure.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 02nov2020 through aware date (b)(6) 2021.There was one similar complaint identified for a total of two complaints during the search period.Review of related documentation: the aia-2000 operator¿s manual a4 appendix 4: error messages states the following.4033] sorter x-axis home overrun.Cause: the home sensor activated improperly following movement of the sorter x-axis.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.

Event Description

The customer called to report that they are getting a constant error 4033 sorter x axis home overrun.Technical support specialist (tss) had the customer open the sorter to inspect for any dropped/loose reagent cups, verify all cup trays are properly seated and performed an all set home command, however the reported error persisted.Field service was dispatched which resulted in delayed reporting of patient results for alpha fetal protein (afp).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting patient results.

• Brand Name: AIA-2000
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 13125969
• MDR Text Key: 284644251
• Report Number: 3004529019-2021-00093
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000 ST
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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