MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and upon arrival, the fse removed the cover and found the cup transfer mechanism was stopped over the incubator.The fse was able to confirm the reported error via the error logs.The fse was able to reproduce the error by performing a cup transfer test, after a few times it failed.The fse replaced the cup transfer assembly along with the incubator and performed all the alignments.The fse performed a cup transfer test several times and all was completed with no errors.The fse inspected and adjusted all temperatures.The fse ran quality control (qc) and verified instrument operation.The aia-900 analyzer is functioning as expected.No further action required by field service.A 13-month complaint and service history review for serial number (b)(4) from (b)(6) 2019 through aware date (b)(6) 2020 was performed for similar complaints.There were two similar complaints including this one identified during the search period.The aia-900 operator's manual under section 12 - flags and error messages states the following: c.Transfer cup pickup failure cause: the cup sensor s063 failed to detect the cup after the cup was grasped.Action: please contact the tosoh local representatives.Check s063, the cup pickup position, and the cup pickup operation.The most probable cause of the reported event is faulty cup transfer assembly.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 they are still having random error 2161 c transfer cup pickup when using the aia-900 analyzer.The customer indicated that they had performed an all set home which passed and they attempted to run a folate calibration which then failed due to this error.The customer is down and they run category a assays.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting beta human chorionic gonadotropin (bhcg) and intact parathyroid hormone (ipth) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba koen; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first buidling; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10869485
• MDR Text Key: 218255580
• Report Number: 8031674-2020-00342
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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