MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problems Mechanical Problem (1384); Communication or Transmission Problem (2896)

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

Event Date 12/05/2019

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.Fse followed up with the customer over the phone to address the reported event.Fse ordered a replacement usb extension for the customer to resolve the issue.No further issues were noted.No further action was required by field service.A 13-month complaint service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2018 through aware date (b)(6) 2019.There was one similar complaint identified during the review period.The a1a-2000 operator's manual under appendix 4- error messages was reviewed.E3008 failure of usb hub: the a1a-360 operator's manual indicates that when the e3008 error message is generated when the analyzer was turned off or the usb is not connected to the analyzer and results from issues with analyzer communication.The most probable cause of the reported event was due to failure of the usb extension.

Event Description

The customer reported receiving error" e3008 failure of usb hub" on their aia-2000st analyzer.The customer stated that the field service engineer (fse) had previously sent in a replacement hub and they just want to discuss the issue.The analyzer is down.Fse was dispatched to address the reported event, which resulted in delay in reporting of patient results for luteinizing hormone (lhii).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, 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: 9535246
• MDR Text Key: 219774472
• Report Number: 8031673-2019-00524
• 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
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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: 022100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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