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 12/08/2023

Event Type  malfunction  

Event Description

A customer reported "4275 incubator slipping detected" error on the aia-900 analyzer.The customer emptied the waste cup through the maintenance menu, but the error persisted.The instrument cover was opened by the customer and a cup was found inside the instrument.The cup was removed, but the error persisted.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 estradiol (e2), follicle stimulating hormone (fsh), luteinizing hormone (lh ii), prolactin (prl) and progesterone (prog ii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A field service engineer (fse) was at the customer's site to address the reported event.The fse confirmed the issue by reviewing the error log.With the instrument powered off, the fse manually turned the incubator turn table and felt resistance from an obstruction.The fse removed the turn table and found that a wash tip had fallen under the turn table and was jammed in a position that was blocking the turn tablet movement.The fse removed the wash tip, reassembled the turn table incubator assembly and manually checked the turn table movement was moving smoothly.Fse could not determine the cause of the reported event.The fse verified the resolution by successfully performing quality control within acceptable ranges.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 through aware date of event for similar complaints was performed for serial number (b)(6).There were no similar complaints identified during the searched period.The aia-900 operators manual under section 12: flags and error messages state the following: [4275] incubator slipping detected cause: while the incubator was moving over the specified distance, the stipulated number of detections did not occur at the home sensor s120.Measurement will be interrupted.Action: please contact tosoh local representatives.Check s120 and pm120 for a possible malfunction.The most probable cause of the reported event is not determined; cause not established.

• 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: 18379841
• MDR Text Key: 331392506
• Report Number: 3004529019-2023-00487
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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