MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation has yet to be completed.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 18jul2019 through aware date (b)(6) 2020.There were two similar complaints including this one that was identified during the searched period.

Event Description

Customer reported that the lh ii with lot number jx13944 failed all three samples in (b)(6)survey after field service engineer (fse) repair.A repeat with new cap samples resulted in high results.Calibration was performed on (b)(6) 2020 and all samples were high out of range.The calibration rates were low compared to the calibration from the tosoh qa lab.A full decontamination was done afterwards.The technical support specialist (tss) had requested for data of the recalibration and a cap repeat after the repair on (b)(6) 2020.The quality control data was sent.The tss had sent a new lot of test cup and calibrator.There was no indication of any patient intervention or adverse health consequences due to discrepancy in reporting of patient results.

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm and reproduce the problem.The fse investigated by checking the temperatures, and all specimen nozzle z-bottom alignments to d-lane, incubator and diluent port z-bottom to d-lane was too low.The fse verified all temperature and cleaned the sample nozzle and flushed.The lh ii was recalibrated and a quality control (qc) was ran and it passed.Probable cause: incompatable test cup/calibrator lot.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku 10586 23; JA 1058623
• MDR Report Key: 10541488
• MDR Text Key: 228946369
• Report Number: 8031673-2020-00254
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: 022930111
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1