MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 02/18/2020

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.Device evaluation by manufacturer: a distributor engineer visited the customer to address the reported event.Fse found misaligned x1 sensor, and resolved the complaint by adjusting the x1 sensor position.The aia-900 analyzer is operational.There was no further action required by distributor engineer.The aia-900, 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-900 operator's manual under chapter 7-1 - list of error messages states the following: s.Loader-x1 home detect error: cause: the home sensor s070 failed to be activated after the sample loader x1-axis moved toward the home position.No further operation will take place.Action: remove the impediment or other cause of the error.Check s070 and pm070 for a possible malfunction.The most probable cause of the reported event was due to misaligned x1 axis sensor.

Event Description

A customer reported getting "4171 s.Loader-x1 home detect error" on the aia-900 analyzer.A distributor engineer was dispatched to address the reported event, which resulted in a delay of estradiol (e2), progesterone ii (prog ii), follicle stimulating hormone (fsh), and cardiac troponin i (ctnl2) patient results.There was no indication of patient intervention, or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

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

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 9986281
• MDR Text Key: 214336118
• Report Number: 8031673-2020-00118
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

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-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1