MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and confirmed the reported event by reviewing the quality control (qc) results.The fse reproduced the reported issue by running lv1 and lv3 qc on tes.The fse investigated the reported complaint by inspecting the instrument temperatures and found the following wash heater to be out of specification at 37.0c, set temperature to 38.5c, +/- 1c of 39.0c per the work instructions.The substrate heater out of specification at 37.3 c, set temp to 39.3c, +/- 1c of 39.0c per the work instructions.The table heater out of specification at 35.4c, set temp to 37.3c, +/- 1c of 37.0c per the work instructions.The fse ran qc on tes lv1 which was low but barely within range.The fse decided to perform a full decontamination on the instrument with brand name clorox bleach.The fse then re-ran qc and precision and tes lv1 and lv3, results were now near observed control manufacturer mean, this resolved the issue.The aia-360 analyzer is functioning as expected.No further action required by field service.A 13-month complaint and service history review was performed for a similar complaints performed on (b)(6) 2021 for st-tes lot a712428 and st-e2 lot a412957 with br 85211 january 19, 2020 to february 19, 2021.There were no similar complaints identified during that search period.The most probable cause of the reported event was due to the wash heater and the substrate heater were both out of specification.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 the quality control (qc) is out of range low.Customer is using br 85211, tes, and e2 (estradiol).Both test cup lots have been in use since (b)(6) 2021 without issues.The site recalibrated both tests after decontamination of the analyzer.The technical support specialist (tss) will send new test cups, calibrators, and mac qc.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting estradiol (e2) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.Customer called back within a few days to report the result for e2 level i range 167-310 and the customer's value was 168.68.Mac qc h706.E2 155, 273, 378 all in range.Tes level 1 86 out of range (91-170), 421, 796.Br 85210.E2 228, 654, 1231 all in range.Tes level i 64 out of range (64.8-120.4), 470, 1184.

Manufacturer Narrative

A 13-month complaint history review and service history were performed for a similar complaint performed for s/n (b)(6).There were no other similar complaints identified during that search period.

• 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
• MDR Report Key: 11529469
• MDR Text Key: 241720387
• Report Number: 8031673-2021-00056
• Device Sequence Number: 1
• Product Code: KHO
• 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
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1