MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the reported issue via visual inspection.The fse was unable to reproduce the reported issue due to a broken electrode wire.The issue was resolved by repairing the broken cable on the diluent electrode.The instrument was validated running a daily check and performing quality control (qc).The qc passed and was within published ranges.The aia-2000 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 13oct2019 through aware date of (b)(6) 2020.There were no similar complaints identified during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: error message: [3000] diluent shortage.Cause: the level sensor of diluent is not detecting fluid.Measurement is suspended.Solution: measurement is automatically resumed after the diluent is replenished.If the diluent level is sufficient, contact tosoh service center or local representatives.The most probable cause of this reported event was the diluent electrode wire was broken.

Event Description

Customer reported an error 3000 diluent shortage - diluent bottle is full the diluent bottle cap has the wires attached still.The customer was requesting for onsite service.A field service engineer was dispatched to address the reported issue which caused a delay in reporting alpha-fetoprotein (afp) patient samples.There was 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, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10977726
• MDR Text Key: 229999748
• Report Number: 8031673-2020-00363
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 11/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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