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 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and confirmed the error via the error log.The fse was not able to reproduce the error.The fse investigated and performed a cup transfer alignment to incubator both in and out positions.The fse ran a cup transfer test ten times with no errors.The fse cleaned the cup sensor on the transfer arm.The fse ran quality control (qc) patients and daily check and all passed.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 28sep2019 through aware date 28oct2020 was performed for similar complaints.There were no similar complaints 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 the cup transfer assembly was out of alignment.Submission of this report does not constitute an admission that the manufacturer's product caused, or contributed to the event.

Event Description

Customer reported a c transfer cup pickup failure 2161 while using the aia-900 instrument.The customer verified that the solid waste was empty and rebooted the analyzer, however, the error persisted.The analyzer is down.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting 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 buidling; 3-8-2 shiba; 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: 10905963
• MDR Text Key: 221017818
• Report Number: 8031673-2020-00348
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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