MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the reported error via the error log.The fse was able to reproduce the error by running an all set home.During the visit, the customer also informed customer that the wash probe 1 nozzle was damaged at the sleeve.The fse confirmed this by looking at the wash probe tip.The fse resolved the issue by replacing the cable 1 bf probe for pulse motor and wash probe 1.The instrument was validated by performing quality control (qc) and the results passed and were within published ranges.The aia-2000 analyzer is functioning as expected.No further action required by field service.The following parts were returned to tosoh instrument service center for investigation: the wash probe assembly was put onto an analyzer.The error was not replicated during wash priming.The part passed.The bf probe pulse motor cable wire resistivity was tested using a multimeter before installing part onto the test bed analyzer.A brown wire running from pm240 to bf-7 was found to be broken and gave an ol ohm reading.No attempt was made to test the part due to the broken wire.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 05oct2019 through aware date (b)(6) 2020.There were no similar complaints identified during the searched period.The aia-2000 operator's manual under section 04 - error messages states the following: [4443] b/f probe 1 home overrun.Cause: the home sensor activated improperly after movement of b/f probe 1.Operation is suspended.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to a broken wire.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer reported an error 4443 b/f probe 1 home overrun while using the aia-2000 analyzer.Prior to calling in to technical support, customer cleaned the wash probe tips.The technical support specialist (tss) advised customer to check wash probe tips to ensure that it was seated well and to also inspect the check waste.Customer indicated that the background check passed and that the substrate solution was made the other day and on the same day the issue was reported.Customer ran two bottles.The wash that was made the other day ran fine.The tss advised customer to perform another run.Customer repeated the background check and it failed.The tss instructed customer to use the substrate bottle 1 instead of bottle 2 and perform another background check.Customer received an error 4443.The tss suggested for customer to check the wash probe tips again for leaks and customer did not see any salt buildup.The customer also indicated that the screws were not loose.The tss advised customer to try an all set home from maintenance and customer did not receive any errors.The tss suggested for customer to version up.When customer attempted another background check, the same error occurred.A field service engineer (fse) 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: 10948926
• MDR Text Key: 220972369
• Report Number: 8031673-2020-00357
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• 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