MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineering (fse) was at customer's site to resolve reported event.Fse confirmed the error in error log but could not reproduce error.Fse checked the sensors and confirmed they were functioning as expected.While fse was troubleshooting, customer reported the sorter was not picking up cups.Fse verified errors in the log and saw multiple dropped cups inside the analyzer also found worn pickup head suction pad and filter.Fse completed all sorter cup pickup and release alignments, replaced the worn suction pad and filter.Fse ran daily check and quality control runs, results passed without errors.No further action required by field service.The aia-900 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4).There were two (2) similar complaints identified during the searched period, which includes this event.The aia-900 operator's manual under section 12 - flags and error messages states: sample rack not moved.Cause: the rack feed detection sensor s072 failed to detect rack movement when step (x1) feed took place.Action: check the direction of the sample rack and also whether or not there are any obstacles.If the trouble reoccurs, contact the tosoh local representatives.Check s072 and the step feed mechanism.Sp measurement has not taken place for one of the following reasons.The specimen could not be treated because the sorter or reagent and tip cover was open during pretreatment or interim reagent dispensing.The reagent could not be dispensed because the reagent and tip cover was open during dispensing of the conjugate.Some other reason.Print and display (rate value): becomes blank.Print and display (concentration value): becomes blank.Rs232c output (concentration value): conforms to the setting that is applicable to the case where no concentration is set in the host.Rs232c output (flag): a.The most probable cause of the reported event was due to worn pickup head suction pad and filter causing misaligned cup pickup head.

Event Description

A customer reported getting error message "2301 sample rack not moved" and sampling pause (sp) flags on the aia-900 analyzer.The customer filled the tips, made sure the reagent and tip cover (rt) was locked, made sure the sorter was closed, opened and closed the sorter to make sure the analyzer saw the stc cups, ejected the racks and sprayed with canned air, then attempted to reboot the analyzer but errors 2301 and sp flags persisted.The customer had an entire tray of stc cups, but 1 out of 20 was skipped.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of intact parathyroid hormone (ipth) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10146399
• MDR Text Key: 228228701
• Report Number: 8031673-2020-00153
• 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
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• 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
• Date Manufacturer Received: 05/22/2020
• 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