MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 08/11/2020

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 field service engineering (fse) was at the customer's site to address reported event.Fse confirmed reported error by reviewing the error log and reproduced the error by attempting an all set home operation.Fse replaced the cup pick-up assembly and adjusted alignments, error 4151 is resolved but error 4123 "specimen z home overrun" occurred.Fse then replaced the s052 sensor, the main board and driver board, but error remains.Fse replaced the specimen dispense z-axis assembly, inspected the sensor associated with z home on the specimen and found it was stuck in the on state.Fse confirmed the sensor was functional by moving it to the cap sensor position and it would operate correctly.Fse tried a new samp board, but there was no change in sensor function.Fse returned the original samp board, inspected the mb board and found a cable was not fully seated, it was labeled samp.Fse reseated the cable and the error did not reoccur.Fse ran quality control without error and within acceptable range.No further action required by field service.The aia-900 analyzer is functioning as expected.The board and cup pick up assembly were returned to tosoh instrument service center for investigation.Functional testing of the sensor board confirmed the resistance between two pins were shorted together, hence causing the sensor board to fail and the cup transfer assembly also failed during functional testing.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-900 operator's manual under section 12 - flags and error messages states: [4123] sample-z home overrun.Cause: the home sensor s052, which is not supposed to be activated after the specimen dispensing arm z moves, was activated.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s052 and also check to see the cause of slipping, and so on, that occurs when pm051 moves to the limit side.[4151] c.Trans-z home detect error.Cause: the home sensor s062 failed to be activated after the transfer y moved toward the home position.A retry will take place and if there is no improvement a mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s062 and pm061 for a possible malfunction.The most probable cause of the reported event was due to faulty cup transfer assembly and mb board (sensor).

Event Description

A customer reported getting "4151 c.Trans-z home detect error" on the aia-900 analyzer.The customer performed all set home function, but error persisted.Prior to contacting the technical support specialist (tss), the customer removed analyzer cover and verified no cups/tips dropped in incubator.The customer cleaned cup pickup, rebooted analyzer and error persisted.Analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient sample 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

Correction: d8, d9, and h6 component codes.

• 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: 10512317
• MDR Text Key: 229123908
• Report Number: 8031673-2020-00247
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1