MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

On 04-mar-2016 a technical service specialists (tss) conducted follow-up with the customer over-the-phone to address the reported event.The tss performed troubleshooting with the customer and instructed the customer to not refreeze br liquid controls, these should not be refrozen.Requested the customer to run fresh controls and now all within range.The aia-360 analyzer was functioning as intended with all issues cleared.No further action required by the tss/fse.The most probable cause of the reported event was due to related to operator error.User refreezing controls.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).

Event Description

On (b)(6) 2016, a customer reported erratic control results (qc) issues after calibration with the aia-360 analyzer.The customer is unable to run prog patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting prog patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: AIA-360
• Type of Device: AIA-360
• 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 (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7410377
• MDR Text Key: 105295973
• Report Number: 8031673-2018-05043
• Device Sequence Number: 1
• Product Code: LCP
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360
• Device Catalogue Number: 019945
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2018
• Distributor Facility Aware Date: 03/04/2016
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/09/2018
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2015
• 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