MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problems Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Noise, Audible (3273)

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

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineering (fse) was at the customer's site to address reported event.Fse reproduced the problem by performing a sample run and found that the main arm is producing the noise while moving.Fse cleaned and lubricated the main guiding rod and timing belt.Fse was able to successfully complete a sample run without any noise.Fse was also able to confirm out of range controls from result printouts and reproduced it by running controls.Fse found a missing tip of the bf probe #1.Fse installed new probe tip for bf probe #1 and cleaned all bf probes.The customer successfully ran quality controls without error and within acceptable range.The customer reported sorter errors later during the night shift.Fse was able to confirm the problem in the error log but was not able to reproduce the error while performing macro cup transfer tests or singular and compound movement test.Fse checked sorter alignments for cups and tips, ran macro again without error.No further action required by field service.The aia-2000 instrument is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no similar complaints identified during the search period.The most probable cause of the reported noise was due to main arm guiding rod and timing belt needed cleaning and lubrication.The most probable cause of the reported out of range controls was due to missing bf probe tip.The most probable cause of the reported sorter error could not be duplicated.

Event Description

A customer reported the aia-2000 instrument is shaking and making a lot of noise.The control results were also reported to be out of range.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for prolactin (prl) and luteinizing hormone (lhii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586-23 ; JA 1058623
• MDR Report Key: 11894985
• MDR Text Key: 256498606
• Report Number: 8031673-2021-00161
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000
• Device Catalogue Number: 022101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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