MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. AIA 900

Model Number AIA 900

Device Problem Mechanical Problem (1384)

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

Event Date 03/06/2020

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 aligning the x1 sensor.The aia-900 analyzer is operational.There was no further action required by distributor engineer.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 other similar complaints found during the searched period.The aia-900 operator's manual under chapter 7-1 - list of error messages states the following: [4171] 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.

• Brand Name: AIA 900
• Type of Device: AIA 900
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city, oh
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city, oh
• Manufacturer Contact: bernadette oconnell ; 6000 shoreline court; suite 101; south san francisco, ca ; 9368143
• MDR Report Key: 9986347
• MDR Text Key: 261265607
• Report Number: 3005529799-2020-00037
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: HO
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2017
• 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