MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The fse was able to confirm the problem by reviewing the error log; the instrument was still in error mode upon arrival.The fse was unable to reproduce the problem after clearing the error.The test cup picking assembly was replaced.The fse performed all alignments for the assembly and ran a twelve-cup transfer evaluation test without any failures.The fse removed the instrument cover, and noticed irregularities with wash trails on the incubator.The fse removed and cleaned the incubator, detector, detector lens, lens chamber, and wash probes.The fse checked the wash position adjustments and removed the wash syringe block, found signs of leakage; the wash syringe block was replaced.The fse performed wash primes and monitored the wash operation.The fse also performed a back flush on the sample nozzle.All quality control (qc) results passed and were within manufacturers package insert ranges.The instrument software was upgraded to version 2.54.No further action required by field service.The aia- 900 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for the, serial number (b)(4), from 30sept2018 through aware date 31oct2019.There were no other similar complaints identified during the review period.The aia-900 operator's manual under section 12 flags and error messages states the following: transfer cup not released.Cause: the holder sensor s063 detected a cup after the cup was released.Action: please contact the tosoh local representatives.Check s063 and the cup release operation.The probable cause of the reported event was due to failure of the test cup picking assembly and faulty syringe block.

Event Description

A customer reported getting sporadic error message 2163 c.Transfer cup not released on the aia-900 instrument.The customer cleaned the sensor prior to calling tech support (ts).Ts also advised the customer to reboot instrument.The customer called back after rebooting the instrument and reported that the error persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of estradiol (e2), luteinizing hormone (lh ii), and beta human chorionic gonadotropin (bhcg) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: ms. oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9380184
• MDR Text Key: 220254724
• Report Number: 8031673-2019-00479
• Device Sequence Number: 1
• Product Code: KHO
• 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: 11/26/2019

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-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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