MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the reported problem by reviewing the error log.The fse noted the analyzer was not down upon arrival and no errors were occurring.The customer had provided the fse with a video recording of the issue occurring and the fse identified the pick up assembly claws were slightly hitting the test cup as the claw was going down to pick up the test cup.The customer confirmed the issue was occurring intermittently.The fse adjusted the claw opening to ensure the claw cleared the test cup with room to pick up the test cup with no errors.The fse ran several cup transfer test along with the customer running test and no issues recurring.The fse validated the analyzer by running quality control (qc) with results within acceptable range.A 13 month complaint history review and service history review for similar complaints was performed thru the aware date for the serial number (b)(6).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: [2161] 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 was due to an alignment issue with the test cup assembly claw, component failure.

Event Description

A customer 2161 (900 only) c.Transfer cup pickup failure on the aia-900 analyzer.The customer confirmed all set home action completes, but the analyzer will not empty test cups from the incubator.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for intact parathyroid hormone (ipth).There is 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: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 18332945
• MDR Text Key: 330704818
• Report Number: 3004529019-2023-00482
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 022930
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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