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

Model Number	AIA-2000 LA
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that they were unable to turn on the computer for their aia-2000 analyzer.The customer tried rebooting a few times without success.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 alpha-fetoprotein (afp).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
Additional Manufacturer Narrative
A field service engineer (fse) conducted a site visit and was able to confirm that the computer was non-responsive for the aia-2000 analyzer.The personal computer (pc) bios was accessible, but unit would not go beyond basic loading and the fse was unable to load windows repair tools.The customer also reported to fse that a generator test was performed a day prior and after the testing the computer became non-responsive; the uninterrupted power supply (ups) was also tested and it was not functional.Fse returned at customer's site at a later date and dismantled old pc and tested hard drive.The hard drive read sector was likely damaged, most likely due to the ups battery cell being swollen and cracked.Fse uploaded the aia-2000 software onto customer work laptop and tested 2000 unit successfully to assure it's functionality.A new computer was ordered along with diagnostic tools for the hard drive.Fse arrived at customer's site the next day, used the diagnostic tools to boot old computer including usb boot key and was unsuccessful; the hard drive for the old pc was damaged.Fse installed new pc and tested unit successfully.Fse completed the replacement of pc with new unit, and restored parameter with usb backup stick.Fse calibrated and validated analyzer with prostate specific antigen (psa) performed quality control (qc) successfully.The aia-2000 analyzer is functioning as expected.No further action required by field service.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 search period.The most probable cause of the reported event was due to failure of the analyzer pc.

• Brand Name: AIA-2000 LA
• Common Device Name: 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: 17322453
• Report Number: 3004529019-2023-00369
• Device Sequence Number: 6365518
• Product Code: KHO
• UDI-Device Identifier: 04560189284623
• UDI-Public: 04560189284623
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K971103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: AIA-2000 LA
• Device Catalogue Number: 022101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown