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

Model Number AIA-2000 ST

Device Problems Failure to Pump (1502); Failure to Align (2522)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by reviewing the error logs and reproduced error 2207 by performing the get corner tips on all racks test.Fse noticed rack position #2 and #3 tip pick up positions needed adjustment and, performed alignment to all positions and reran the get corner tips on all rack test without error.The error 3060 was intermittent and reoccurred after running several racks, fse replaced the incubator assembly to resolve the error.Fse performed all necessary alignments and verified the temperature was in acceptable range.The customer performed quality control and patient sample runs without error and within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.The aia-2000, serial number (b)(4), was installed on (b)(6) 2021 a complaint history review and service history review for similar complaints was performed from installation date through aware date.There were three (3) similar complaints identified during the searched period, which includes this event.The aia-2000 operator's manual under appendix 4: error messages states the following: [2207] no tip acquired by sorter cause : no tip was detected during the tip attachment check.If retry fails, measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.[3060] b/f table mixing failure cause : the mixing check sensor of the b/f table mixing motor failed to detect a mixing operation.The current measurement will be flagged (io flag) and new measurements will be suspended.Solution : contact tosoh service center or local representatives.The most probable cause of the reported event is due to misaligned tip pickup assembly and failure of the incubator assembly.

Event Description

A customer reported error messages "2207 no tip acquired by sorter" and "3060 bf table mixing failure" on the aia-2000 analyzer.Analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for intact parathyroid hormone (ipth).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number (b)(6), which confirmed that there were no nonconformance, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.

• 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: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 13814313
• MDR Text Key: 295233915
• Report Number: 3004529019-2022-00058
• 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,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• 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: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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