MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problems Electrical /Electronic Property Problem (1198); Failure to Pump (1502)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

Customer called to report error 4014, spec.Sy home overrun on the aia-360.Customer states the daily check passed but the error occurred when trying to run the controls.Customer performed all set home but the error persists.Fse dispatched.Customer is t&m.

Manufacturer Narrative

Customer called to report error 4014, spec.Sy home overrun on the aia-360.Customer states the daily check passed but the error occurred when trying to run the controls.Customer performed all set home but the error persists.Fse dispatched.Field service engineer confirmed the problem by looking at the prints out and reproduced the error by attempting to run the analyzer.After troubleshooting the engineer found multiple issues with the instrument.The wire leads to the reagent were frayed, causing the miss connections with reagents bottles.Diluent motor was jammed, and engineer was not able to move up and down with the instrument off.Substrate motor was jammed, and engineer was not able to move up and down with the instrument off.B/f syringe motor jammed, and engineer was not able to move up and down with the instrument off.Replaced all the wire leads and the cables from the back of the instrument to the reagent and waste bottles.Replaced the diluent, substrate and b/f syringe units.Performed pm.Returned analyzer to normal operation.

• Brand Name: AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360
• 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: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 13406250
• MDR Text Key: 295707455
• Report Number: 3004529019-2022-00041
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• 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: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AIA-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1