MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Obstruction of Flow (2423)

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

Event Date 09/16/2019

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 reported error and reproduced the problem by running a patient sample.Fse inspected the diluent tubing and noticed it was kinked on the back of the instrument.Fse ran liquid sense test and other functional test without any further issues.Fse successfully completed quality control run without any errors 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 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 aia-900 operator's manual under section 12 - flags and error messages states: [2105] diluent suction error: cause: the tip did not touch the liquid level during suction of the diluent.A retry will be carried out, and if there is no improvement a ds flag will be attached to the measurement result.Action: if the trouble reoccurs, contact the tosoh local representatives.Check the diluent, the adjustment of the suction position, the liquid level detection sensor s053, the liquid level detection operation, and also the liquid level detection sensitivity.The most probable cause of the reported event is due to pinched tubing on rear of the instrument.

Event Description

A customer reported getting error message "2105 diluent suction error" during sample run on the aia-900 instrument.Instrument is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of intact parathyroid hormone (ipth), 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, japan 10586-23 ; JA 1058623
• MDR Report Key: 9120920
• MDR Text Key: 220509353
• Report Number: 8031673-2019-00394
• 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: 09/25/2019

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: 09/16/2019
• Initial Date FDA Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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