MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The fse was able to confirm the complaint by looking at the error log and finding entries of loader step feed failure.The error was reproduced by running a daily and getting loader step feed failure.The issue was resolved by re-adjusting x1 flag to the vertical position when x1 is in the sampling position.The instrument was validated by performing quality controls (qc); results passed and were within published ranges (per package insert).No further action required by field service.The aia-900 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for the serial number: (b)(4) from 23aug2018 through aware date of 23sept2019.There were no other similar complaints identified during the review period.The aia-900 operator's manual under section 12 flags, and error messages states the following: 2300 - s.Loader step feed failure; cause: the pitch sensor s071 failed to go on after the step feed.Action: check to see if there is any impediment to the sample rack feed.If the trouble reoccurs, contact the tosoh local representatives.Check s071 and the step feed mechanism.The probable cause of the reported event was due to a misalignment of the sample loader step feed x1 flag.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported getting error 2300 s.Loader step feed failure on the aia-900 instrument.The customer stated that they had a sample rack jam occur and after clearing the rack jam, they received the 2300 sample loader step feed failure.The customer was able to perform the all set home command without error.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of cardiac troponin i (ctnl 2), and creatine kinase mb isoenzyme (ck-mb) patient results.There was no indication of patient intervention, or adverse health consequences due to the delay in reporting.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: ms. oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9168330
• MDR Text Key: 216645411
• Report Number: 8031673-2019-00403
• 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: 10/01/2019

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-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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