MAUDE Adverse Event Report: TOSOH HI-TEC AIA-360

Model Number AIA-360

Device Problems Mechanical Problem (1384); Device Operational Issue (2914)

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

Event Date 08/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on 09-aug-2017 a field service engineer replaced the sampler assembly in order to resolve the issue.The fse confirmed that no results were reported out in error.A 13-month complaint history review for serial number (b)(4) found no similar complaints during this time period.The aia-360 operator's manual under section 7-2: list of flags, states that a

Event Description

On (b)(6) 2017, a customer reported that on (b)(6) 2017 the laboratory received an estradiol (e2) result of

Manufacturer Narrative

(b)(4).Report source: under the above section "user facility" was incorrectly selected.The only report source is "health professional".

Event Description

N/a.

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Date of event: (b)(6) 2017.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSOH HI-TEC; 1-37 fukugawa minami-machi; shunan-shi 746-0042, ja, ; JA
• MDR Report Key: 6844557
• MDR Text Key: 85918509
• Report Number: 8031673-2017-00021
• Device Sequence Number: 0
• Product Code: CHP
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Distributor Facility Aware Date: 09/12/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/25/2018
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1