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 Problem High Readings (2459)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

A customer reported that the quality control (qc) is high for progesterone.The customer was advised to send the latest calibration.A review of the calibration indicated imprecision of cal 1.A field service engineer (fse) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for progesterone.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A field service engineer (fse) conducted a site visit to address the reported event.The fse confirmed the reported complaint by reviewing the result printouts.The fse was able to reproduce the high results by running progesterone qc.The fse suspected contamination of the analyzer.The fse decontaminated the analyzer and ran the progesterone calibration and noticed the rates were too low.The fse replaced the detector, all system valves, and wash heater which did not resolve the issue so the fse re-installed the original parts.The fse is suspecting environmental contamination might be affecting the analyzer.The fse also ran total triiodothyronine (tt3) calibration and precision and results were within published ranges.The problem is unresolved.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2021 through aware date (b)(6) 2022.There were 2 similar complaints identified during the search period including this event.The most probable cause of the reported event is unknown.This case was created on july 05, 2022 due to a miscommunication between the technical support specialist (tss) and the field service engineer (fse); therefore, this mdr is being submitted late.

• 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 ; 6506368314
• MDR Report Key: 14955963
• MDR Text Key: 304520117
• Report Number: 3004529019-2022-00122
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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