MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

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

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at customer's site to resolve reported event.Fse confirmed the reported error by reviewing the error log but was unable to reproduce the error.While troubleshooting, fse checked the eki board ad values and it was in range, ran macro test for tip pick up, observing tip pick up action.Fse cleaned the sample nozzle, ran total triiodothyronine (tt3) control level 1 five times to check results and no issues found.Fse suspected possible intermittent cable error and resolved the problem by replacing the cable main arm sample head.Fse validated analyzer by running tt3 sample and quality control; runs completed successfully without error.No further action required by field service.The aia-2000 analyzer is functioning as expected.The aia-2000, serial number (b)(4), was installed on (b)(6) 2019.A complaint history review and service history review for similar complaints was performed from installation date (b)(6) 2019 through aware date (b)(6) 2019.There were no other similar complaints identified during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: [2061] tip detachment failure by main arm cause: a tip was detected by tip detachment check.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.[2062] specimen level detection failure by main arm cause: no liquid level was detected even after the specimen dispensing tip was lowered to the bottom of the container.The measurement result will be flagged (ss flag).Solution: verify that the specimen is in the correct position and its volume is sufficient.If retry fails, contact tosoh service center or local representatives.[2085] air detected during diluent suction by main arm cause: during diluent suction, it was determined that the tip failed to touch the liquid surface.If retry fails, the measurement result will be flagged (ds flag).Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to faulty main arm sample cable.

Event Description

A customer reported getting error messages "2085 air detected during diluent suction by main arm", 2061 "tip detachment failure by main arm" and 2062 "specimen level detection failure by main arm" on the aia-2000 analyzer.The customer also found sample tips left in the reagent test cups.The analyzer is down.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for follicle stimulating hormone (fsh), luteinizing hormone (lhii), beta human chorionic gonadotropin (bhcg), intact parathyroid hormone (ipth), prolactin (prl) and estradiol (e2).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number (b)(6) , which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 9528258
• MDR Text Key: 220006003
• Report Number: 8031673-2019-00523
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• 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?: Yes
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1