MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

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

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineer (fse) arrived at the user facility and confirmed the reported event by observing that the sampling nozzle was completely clogged.The fse proceeded to perform sampling nozzle flush with bleach, followed by di water, alcohol, and air.The fse then adjusted the pressure board per manufacturer's specifications.The aia-2000 was validated by running quality control on fsh, which passed within published ranges.No further action was required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 07-apr-2018 through aware date 07-may-2019.There were no other similar events reported during the searched period.The aia-2000 operator's manual under a4.Appendix 4: error messages, states the following: 2070 clogging detected during specimen suction by main arm.Cause: the negative pressure detected after specimen suction exceeded the standard.The specified amount of specimen may not have been obtained because the sampling nozzle was blocked.The measurement result will be flagged (sc flag).Solution: verify that the specimen is free of solid substances (such as fibrin) or that there is sufficient volume of specimen if it is prepared in the primary tube, and retry the measurement.If retry fails, contact tosoh service center or local representatives.The most probable cause of the reported event was due to a clogged sampling nozzle.

Event Description

A customer reported getting error message "2070 clogging detected during specimen suction by main arm" while running patient samples on the aia-2000 instrument.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for intact parathyroid hormone (ipth), follicle stimulating hormone (fsh), beta human chorionic gonadotropin (bhcg), and prolactin (prl).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 8648304
• MDR Text Key: 151781620
• Report Number: 8031673-2019-00184
• 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: 05/28/2019

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-2000
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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