MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

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

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) followed up with the customer via telephone, and advised customer to power off and on the aia-2000 which resolved reported error.The aia-2000 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 07jan2019 through aware date 07feb2020.There were no similar complaints identified during the searched period.The aia-2000 operator's manual under section 04 - error messages states the following: [4241] hybrid arm y-axis home detection failure.Cause: the home sensor failed to activate after the hybrid arm y-axis moved toward the home position.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The most probable cause of the reported event is unknown.Submission of this report does not constitute an admission that the manufacturer's product caused, or contributed to the event.

Event Description

Customer reported that they are getting a constant error 4241 hybrid arm y axis home detect.The technical support specialist (tss) had the customer perform an all set home command and the same error persists.The customer switched to their second aia-2000 analyzer to continue their samples.A field service engineer (fse) was dispatched to address the reported issue, which caused a delay in reporting alpha-fetoprotein (afp) patient samples.There was no indication of any patient intervention, or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 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: 10671806
• MDR Text Key: 213501635
• Report Number: 8031673-2020-00298
• 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

• 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: 022101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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