MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. AIA-900

Model Number AIA-900

Device Problems Contamination /Decontamination Problem (2895); Output Problem (3005)

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

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the low to high results by viewing the printout.The fse was unable to reproduce the low to high results.The fse decontaminated the instrument and replaced the two-way solenoid valve for the bf probe 2.The fse also checked the wash probes position alignment and all alignments for the specimen nozzle z-axis, cleaned the detector lens and checked for leaking sample nozzle or specimen syringe which checked ok.The instrument was returned to operational status.The aia-900 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review for similar complaints were performed for the serial number: (b)(4) from 19jul2019 through aware date (b)(6) 2020.There were no similar complaints identified during the searched period.The most probable cause of the reported event was contamination and two-way waste solenoid valve.

Event Description

Customer reported a low to high erroneous results on two different patient samples and on two different assays estradiol (e2) and progesterone (prog ii).There was no patient involvement and the results were repeated.The customer added that the decontamination was recently done but did not provide a date.The technical support specialist (tss) asked for a data and a short precision run.Customer called back into the technical support line to report that another sample had an erroneous result.A beta human chorionic gonadotropin (bhcg) was ran on a patient and the result was around 500.The patient recently returned to the clinic and had another bhcg ran and the result was 386 on repeat it was greater than 400.Customer ran a dilution twice and still needs to dilute further.Customer requested service.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting estradiol (e2), progesterone (prog ii) and beta human chorionic gonadotropin (bhcg) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Correction: medical device problem code.Additional information: investigation findings.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• MDR Report Key: 10537496
• MDR Text Key: 231226808
• Report Number: 3005529799-2020-00050
• 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
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• 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: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1