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 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) followed up with the customer over the phone to address reported event.Fse reviewed the error log and confirmed the reported error and the error was also reproduced when customer attempted a sample run.Fse instructed the customer to perform an all set home, eject all racks, remove all test cups and restart the run; run completed without further errors.No further action required by field service.The aia-2000 instrument is functioning as expected.The aia-2000, serial number (b)(4), was installed on (b)(6) 2019.A complaint history review and service history review for similar complaints was performed from installation date through aware date.There were no other similar complaints identified during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: [4407] incubator rotation motor overrun to positioning sensor cause: the positioning sensor activated improperly during rotating of the incubator.New measurement will not start.The measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.[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.The most probable cause of the reported event is unknown.

Event Description

A customer reported getting error message "4407 incubator rotation motor overrun to positioning sensor" on the aia-2000 instrument.The customer was able to perform an all set home operation which reset the analyzer.The customer resumed running controls and the entire run aborted with error 2180, x-axis cup transfer cup detection failure.The instrument is down.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for follicle stimulating hormone (fsh) and 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

Corrected data: serial number updated from (b)(6) to (b)(6).The aia-2000, serial number (b)(6), was installed on (b)(6) 2019.A complaint history review and service history review for similar complaints was performed from installation date 11jul2019 through aware date 18jun2020.There were no other similar complaints identified during the searched period.

• 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: 10228408
• MDR Text Key: 198354723
• Report Number: 8031673-2020-00180
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1