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

Model Number AIA-2000 ST

Device Problem Break (1069)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

Customer called to report the screw to the b/f wash probe #3 had broken off.Customer stated that she was doing the weekly maintenance when the screw broke.Customer also reported the sorter draw was not opening when the button was pushed.Fse dispatched.The analyzer is down.Field service was dispatched to address the reported event which resulted in delayed reporting of patient results for follicle stimulating hormone (fsh), intact parathyroid hormone (ipth), and luteinizing hormone (lhii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting patient results.

Manufacturer Narrative

An investigation was performed in response to a complaint of a broken screw on the aia-2000.It is not known whether the device was being used for treatment or diagnosis at the time of the complaint.By phone, technical support received the complaint and dispatched field service.By phone, field service identified the broken thumbscrews and sent replacement parts.Field service confirmed the washers and thumbscrews were replaced and verified the analyzer was functioning as expected.The washer had degradation problems causing component failure.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.The instrument has been installed for more than one year from the aware date of the event so no product history review was required.No products were returned for further investigation.The investigation confirmed a failure of the aia-2000 to meet specifications or intended use.The washer and thumbscrews exhibited degradation due to component failure.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 26sep2020 through aware date (b)(6) 2021.There were no similar complaints identified during the search period.The aia-2000 operator¿s manual section 9.Maintenance states the following.The 9.2 weekly maintenance: 9.2.1 cleaning b/f wash probes.The 9.2.1.1 open the b/f unit cover: make sure that the aia-2000 has stopped operation, then push the b/f probe button sheet key.After the lock is released, open the b/f unit cover.Close the aia-2000 system program.A dialog box prompting you to replace the substrate will appear.Simply ignore this (push no button) if planning to continue assay operations.Turn off the main power.B/f wash probe tips are constantly in contact with specimens which may contain infectious substances, so always wear gloves when replacing and cleaning probes.Be sure to turn the system power off before performing maintenance tasks.Personal injury may result from getting caught in moving mechanical parts of the system.The 9.2.1.2 removing b/f wash probes: loosen the securing screws for the four b/f wash probes and remove them by lifting upward.The 9.2.1.3 cleaning b/f wash probes: pull off the b/f wash probe tips from each of the b/f wash probes.Clean the removed the b/f wash probe tips for approximately 5 minutes in an ultrasonic neutral detergent bath, then wash with deionized water.If still not clean, replace with new probe tips.(part no.: 0020107).After cleaning, reattach the probe tips to their probes.The b/f wash probe tips are inserted firmly with the stainless steel pipe passing through the center of probe tip.The stainless steel pipe at the center should protrude slightly past the probe tip when correctly installed.Reinstall b/f wash probes to their position and tighten the securing screws.Improper installation of the b/f wash probe tips may cause inaccurate assay results.The 9.2.1.4 installing b/f unit: reinstall b/f wash probes to their position and tighten the securing screws.Close the b/f unit cover.The 9.2.2 cleaning the substrate lines: if the substrate lines became dirty, inaccurate assay results may be caused, perform the following procedures once a week to clean the substrate lines after end of assay.Replace the substrate bottle with the substrate replacement solution (70% ethanol).Click the replace substrate button on the operation panel (toolbar) to start the substrate replacement sequence.Repeat the foregoing procedure three times.

• 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: 12866597
• MDR Text Key: 285064452
• Report Number: 3004529019-2021-00071
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• 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
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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