MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Failure to Align (2522)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by reviewing the error logs, but was not able to reproduced error.While troubleshooting, fse observed functionality of the instrument while performing sample run and no damage was observed.Fse lubricated the hybrid arm tracks and sample nozzle spring, cleaned sample nozzle and cup pickup fingers and block, performed z-axis home position check, performed all alignments and found that the sample nozzle detach needed significant adjustment, fse adjusted the sample nozzle detach and proactively adjusted the rtc lane x.Fse validated the instrument by performing quality control run, all results passed without error and within acceptable range.No further action required by field service.The aia-2000 instrument 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)(4).There were no other similar complaints found during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: [4253] hybrid arm z-axis home overrun.Cause : the home sensor activated improperly after movement of the hybrid arm z-axis.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.The most probable cause of the reported event is due to misaligned sample nozzle to tip detach.

Event Description

A customer reported getting error message "4253 hybrid arm z axis home overrun" on the aia-2000 instrument.Instrument is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for luteinizing hormone (lhii), intact parathyroid hormone (ipth) and follicle stimulating hormone (fsh).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-2000
• 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: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12678126
• MDR Text Key: 277885417
• Report Number: 3004529019-2021-00057
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000 ST
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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