MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Jam (2983)

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

Event Date 03/10/2020

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.A field service engineering (fse) followed up with the customer over the phone to resolve reported event.While troubleshooting with the customer over the phone, fse confirmed the reported issue and reproduced issue by performing a rack rotation test.Fse found that the customer had forced the pitch sensor out of alignment by accidently jamming a rack in the sorter thus knocking the pitch sensor out of alignment.Fse assisted the customer in realigning the x1 pitch sensor to resolve the issue.The customer validated the instrument by running quality control, result passed within acceptable ranges.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 through aware date of event for similar complaints was performed for serial number (b)(4).There were no other similar complaints found during the searched period.The a1a-900 operator's manual under section 12 - flags and error messages was reviewed.[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 most probable cause of the reported event is due to x1 pitch sensor was out of alignment.

Event Description

The customer reported getting error "2300 sample loader step feed failure" after a sample rack jam on the aia-900 instrument.Technical support specialist (tss) instructed the customer to remove all sample racks and then inspect the sample tube/cup detection fingers and customer confirmed all were present and extended in place, but the error persists.The customer is unable to process samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for beta human chorionic gonadotropin (bhcg), follicle stimulating hormone (fsh) and prolactin (prl).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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; 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 10586-23 ; JA 1058623
• MDR Report Key: 9889891
• MDR Text Key: 261055067
• Report Number: 8031673-2020-00095
• 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
• Type of Report: Initial
• Report Date: 03/25/2020

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-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: No
• 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