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 02/17/2020

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) was at customer's site to resolve reported event.Fse confirmed the error by reviewing the error log but was unable to reproduced error.Fse performed alignment checks, and the y-axis alignments were off for tip attachment and all tip rack positions.Fse resolved the reported issue by adjusting all positions on the tip rack to be within specifications.Fse also performed alignment checks on all other specimen nozzle positions and liquid sensing; all passed within specification.Fse validated the instrument by running qc, results completed without error and within acceptable range.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).There were two (2) similar complaints identified during the searched period, which includes this event.The aia-900 operator's manual under section 12 - flags and error messages states: [4124] sample-z bump.Cause: the specimen cap rear-end collision sensor s054 was activated while the specimen dispensing arm z was moving toward the home position.A ss flag will be attached to the measurement result.Action: if the cap is on the specimen, remove it and perform measurement once again.If it is not, contact tosoh local representatives.Check s054 and pm051 for a possible malfunction.The most probable cause of the reported event is due to misalignment of the sample nozzle y-axis to the tip rack positions.

Event Description

A customer reported getting error message "4124 sample-z bump" on the aia-900 instrument.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of intact parathyroid hormone (ipth), prolactin (prl), estradiol (e2), follicle stimulating hormone (fsh) and luteinizing hormone (lhii) 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; 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: 9925580
• MDR Text Key: 261051186
• Report Number: 8031673-2020-00108
• 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: 04/08/2020

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: 02/17/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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