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 09/25/2020

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.The customer informed the fse there was buildup of tips and cups in the waste, and had cleared most of them.Fse confirmed reported error by reviewing the error log, but was unable to reproduce the error.Fse removed the waste chute, and thoroughly cleaned all serum build up.Fse reattached the waste chute and verified alignments, ran quality controls, and run completed successfully without errors and within acceptable range.No further action required by field service.The aia-900 analyzer 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 five (5) similar complaints identified during the searched period, which includes this event.The aia-900 operator's manual under section 12 - flags and error messages states: (b)(4).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.(b)(4).C.Trans-z home overrun cause: the home sensor s062, which is not supposed to be activated after the cup transfer z-axis moves, was activated.No further operation will take place.A mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s062, and also check to see the cause of slipping, and so on, that occurs when pm061 moves to the limit side.The most probable cause of the reported event was due to serum build up in waste system.

Event Description

A customer reported getting "4151 c.Trans-z home detect error and 4153 c.Trans-z home overrun error messages on the aia-900 analyzer.The customer stated these are ongoing errors.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 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.

• 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
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10684916
• MDR Text Key: 211558103
• Report Number: 8031673-2020-00314
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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