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 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

On 26-oct-2016, an fse conducted follow-up with the customer over-the-phone to address the reported event.The customer states that the instrument was bleached cleaned and still low.The e fse asked the customer to make new substrate and rerun both qc (mac and br).The customer sates a quote is needed before service can be approved.On 31-oct-2016 the fse called the customer who reported that all of assays are working except tropnin is low on level 1.The customer states will continue to run.Customer has given the ok to repair.No further action required by field service at this time.The most probable cause of the reported event -no further follow up.(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 ctnl2 control recovery issues with the aia-360 analyzer.The customer states recalibrated twice and opened new qc, also made new wash, diluent and substrate, however, out of range.The customer is unable to run ctnl2 patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting ctnl2 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: 7419295
• MDR Text Key: 105423119
• Report Number: 8031673-2018-05049
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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: 04/10/2018
• Distributor Facility Aware Date: 10/20/2016
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/10/2018
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2010
• 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