MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

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

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the reported issue via the error log of 18 flags out of approximately 50 samples.The fse was also able to reproduce the reported issue by running several samples.The fse also checked the main arm sample nozzle and it was clear of any buildup.The fse also inspected the sample nozzle pressure, offset 250, gain s34; within normal range.The fse checked the beltline alignment; tip is centered in sample tube.The fse lubricated sample syringe and sampling assembly mechanics; exercised sample syringe several times in maintenance program.Customer had controls ready to run; all controls in range, no flags.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 10jul2019 through aware date 10aug2020.There were seven similar complaints including this one that were identified during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: error message: [2086] abnormal pressure detected during specimen suction by main arm.Cause: abnormal suction was detected during specimen suction, possibly due to the following causes: the specimen has high viscosity.A half-solid substance floating in the specimen, such as fibrin, was ingested.Air was ingested.Measuring operation is resumed and the measurement result will be flagged (uc) flag.Solution: verify that the specimen is free of solid substances (such as fibrin) or bubbles on the surface and retry the measurement.If the error persists, but the result is judged normal, the specimen viscosity may be high.In this case, the uc flag attached to the result can be deleted later.If the error still cannot be solved, contact tosoh service center or local representatives.The most probable cause of the reported event is lubrication of the main arm assembly and syringe was needed.

Event Description

Customer reported an error flag uc on the aia-2000 analyzer.Service was onsite for this issue in the past and the issue had returned.A field service engineer was dispatched to address the reported issue which caused a delay in reporting intact parathyroid hormone (ipth) 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: 10488924
• MDR Text Key: 216155941
• Report Number: 8031673-2020-00245
• 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: 09/03/2020

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-2000
• Device Catalogue Number: 022101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/03/2020
• 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