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

Model Number AIA-900

Device Problem Noise, Audible (3273)

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

Event Date 07/22/2022

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer¿s site to address the reported event.Fse confirmed the complaint by reviewing the error logs and was able to reproduce the error by turning on the analyzer.While troubleshooting, error message 2062 tip remove appeared.Fse found many tips and removed them from the reagent tray and loader area.The fse pushed down the tip rack to release it from being stuck which was making the grinding noise.Fse resolved the complaint by moving the detach tip plate, releasing the tip rack, and removing the tips.Fse repaired and validated the analyzer by successfully performing quality control run without error and within acceptable range.No further action required by field service.The aia-900 analyzer is functioning as expected.(b)(4).The aia-900 operator's manual under section 12: error messages states the following: (4233) reag/tip-x home overrun cause: the home sensor s090, which is not supposed to be activated after the reagent loader moves, was activated.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s090 and also check to see the cause of slipping, and so on, that occurs when pm090 moves to the limit side.(2062) tip removal error cause: a tip was detected during the tip removal check.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: if the trouble reoccurs, contact the tosoh local representatives.The most probable cause of the reported event was due to the tips on the reagent lanes and friction problem with the sampler.

Event Description

A customer reported repeated error messages 4233 reagent/tip-x home overrun on the aia-900 analyzer.There was an audible grinding noise and the manual cover could not be opened.A field service engineer (fse) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for estradiol (e2), luteinizing hormone (lh ii), and prolactin (prl).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: 15180766
• MDR Text Key: 305105120
• Report Number: 3004529019-2022-00142
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2022
• 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: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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