MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineer (fse) was at the customer's site to address the reported issue.Fse confirmed barcode read errors by reviewing the error log.Fse found the customer was placing the barcode label too low on the tube preventing it from being read; the customer was notified and trained on proper placement of labels.Fse confirmed customer's reports of patient samples not correlating.Fse could not reproduce problem since the customer did not have a second analyzer for comparison.While fse was troubleshooting, the substrate dispense arm was found dirty, which was possibly causing inconsistent dispensing of substrate.Fse cleaned and verified proper flow.Fse successfully performed daily check and quality control run; results passed within the acceptable range.The aia-360 analyzer returned to operation.No further action required by field service.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 was one similar complaint identified during the searched period.The st aia-pack ca27.29, ca 125 and cea analyte application manual states the following: specimen processing.Preparation: following specific instructions in the operator's manual for the analyzer, place samples on the instrument appropriately.Assay procedure: i) ensure a sufficient quantity of st aia-pack (27.29/ca125/cea) test cups for the number of samples to be run.Ii) load patient samples as instructed in the operator's manual and proceed with analysis.The most probable cause of the patient samples not collating was due to dirty substrate dispense line and the probable cause of the barcodes not reading consistently was due to operator error, improperly placing the labels on the tubes.

Event Description

A customer reported patient sample results for ca 125, ca 27.29, cea runs on the aia-360 analyzer do not correlate with their reference lab results.Customer also stated the barcode reader is not scanning barcodes consistently.A field service engineer was dispatched to address the reported event.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-360
• Type of Device: AIA-360
• 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: 10228396
• MDR Text Key: 228228832
• Report Number: 8031673-2020-00163
• 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: 07/02/2020

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-360
• Device Catalogue Number: 019945
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 07/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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