MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

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

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the reported error from the error log.Fse also noted on the error log that error 4163" x-axis cup transfer z-axis home overrun" had occurred.Fse reproduced the errors when running a test of sample cups.Fse checked alignment of the x axis cup transfer to bf table and found it was out of alignment.Fse reset alignment and tested with macro and it was good.Fse attempted a sample run test and again cup was jammed in bf table due to alignment not holding, and errors 4443 "b/f probe 1 home overrun" and 4163 occurred.Fse replaced the bf table and reset all alignments and temperature, ran over 40 sample cups without errors.The customer successfully completed a daily check run, qc and patient runs also completed without error and within acceptable range.No further action required by field service.The aia-2000 instrument is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no similar complaints identified during the search period.The aia-2000 operator's manual under appendix 4: error messages states the following: [2180] x-axis cup transfer cup detection failure.Cause: the s082 cup-gripping sensor failed to detect a cup before the cup pickup operation.The measurement result will be flagged (mf flag or se flag).Solution: contact tosoh service center or local representatives.[4163] x-axis cup transfer z-axis home overrun.Cause: the home sensor activated improperly after movement of the x-axis cup transfer z-axis.If this occurs, the current measurement result will be flagged (mf flag) and new measurements will be suspended.Solution: contact tosoh service center or local representatives.[4443] b/f probe 1 home overrun.Cause: the home sensor activated improperly after movement of b/f probe 1.Operation is suspended.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to worn bf table.

Event Description

A customer reported getting error message "2180 x-axis cup transfer cup detection failure" on the aia-2000 instrument.The customer performed a version up, but error persisted.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for follicle stimulating hormone (fsh).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

The b/f table was returned to tosoh instrument service center for investigation.Functional testing confirmed the reported event was due to failure of the b/f table.The most probable cause of the reported event was due to failure of b/f table.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 9986283
• MDR Text Key: 228350332
• Report Number: 8031673-2020-00116
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1