MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.Device evaluation by manufacturer: a field service engineering (fse) was at the customer's site to address reported event.Fse confirmed reported error by reviewing the error log and reproduced the error by performing a diluent prime.Fse found diluent check valve leaking and replaced it.Fse successfully validated instrument by performing quality control run without error and within acceptable range.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 two (2) similar complaints identified during the searched period, which includes this event.The aia-2000 operator's manual under appendix 4: error messages states the following: [2085] air detected during diluent suction by main arm cause: during diluent suction, it was determined that the tip failed to touch the liquid surface.If retry fails, the measurement result will be flagged (ds flag).Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to failure of the diluent check valve.

Event Description

A customer reported getting error message "2085 air detected during diluent suction by main arm and leaking fluid" on the aia-2000 instrument.Instrument is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for estradiol (e2), luteinizing hormone (lhii), follicle stimulating hormone (fsh), beta human chorionic gonadotropin (bhcg) and prolactin (prl).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: 12010846
• MDR Text Key: 256734289
• Report Number: 8031673-2021-00187
• 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: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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