MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

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

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: the aia-360 operator's manual under section 7-2: list of flags states the following: dl is generated when the substrate dispensing amount is less than the specified amount or the lamp intensity of the fluorescence detector is low.Solution: if the dl flag is attached, replace the substrate and repeat assay.If the dl flag appears again, contact the service department.The st aia-pack intact pth application analyte manual states: evaluation of results: quality control - in order to monitor and evaluate the precision of the analytical performance, it is recommended that commercially available control samples be assayed daily.The minimum recommendations for the frequency of running internal control material are: after calibration, two levels of controls are run in order to accept the calibration curve.The two levels of controls are also repeated after calibration when certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, maintenance of the wash probe or detector lamp adjustment or change).After daily maintenance, at least two levels of the control should be run in order to verify the overall performance of the tosoh aia system analyzers.If one or more control sample value(s) is out of the acceptable range, it will be necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the regulatory agency under which the laboratory operates.The most probable cause of the reported event is pending investigation completion.

Event Description

A customer reported out of range high quality control (qc) result on the aia-360 analyzer.The customer stated the qc result was high for both fresh qc and 3 days old qc.Customer also reported getting dl flag on the repeat qc run.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for intact parathyroid hormone (ipth).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Event Description

N/a.

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.The 3-way solenoid valve was returned to tosoh instrument service center for investigation.Visual inspection confirmed the wiring of the valve was cut, therefore no further testing was performed.The most probable cause of the reported event was due to faulty 3-way solenoid valve.

Manufacturer Narrative

Please refer to g4 for corrected data.The date received by manufacturer was missing from the submitted follow up #1.

Event Description

N/a.

• 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
• MDR Report Key: 9297705
• MDR Text Key: 220346376
• Report Number: 8031673-2019-00439
• 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,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1