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 03/03/2020

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 engineer (fse) was at the customer's site to address the reported event.Fse confirmed the errors by reviewing the analyzer printouts and reproduced the error by running cal 1 as a patient sample.Fse performed decontaminated and preventive maintenance.Ipth calibration and quality control were completed successfully without error and within acceptable range.No further action required by field service.The aia-360 analyzer is functioning as expected.A 13-month complaint, service and lot history review through aware date of event for similar complaints was performed for serial number (b)(4) and st-pth lot j415228 with calibration lot a735271.There were no other similar complaints found during the searched period.The st aia-pack intact pth analyte application manual states the following: calibration.Calibration curve.The calibrators for use with the st aia-pack intact pth are prepared gravimetrically.The calibration curve for the st aia-pack intact pth is stable for up to 90 days.Calibration stability is monitored by quality control performance and is dependent on proper reagent handling and aia system maintenance according to the manufacturer's instructions.Recalibration may be necessary more frequently if controls are out of the established range for this assay or if certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, or detector lamp adjustment or change).For further information regarding instrument operation, consult the aia system operator's manual.The most probable cause of the reported event was due to biological contamination.

Event Description

A customer reported getting out of range high calibration 1(cal 1) rate for intact parathyroid hormone (ipth) on the aia-360 analyzer.The customer was running st-pth lot j415228 with calibration lot a735271.The customer recalibrated using same lot, but error persisted.Technical support specialist (tss) advised the customer to recalibrate with a different lot.The customer followed up after recalibrating with a different lot of calibrator, and reported same errors occurred.The customer is unable to process sample runs.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of intact parathyroid hormone (ipth) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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: 10019352
• MDR Text Key: 261041466
• Report Number: 8031673-2020-00122
• 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: 04/30/2020

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: 03/03/2020
• Initial Date FDA Received: 05/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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