MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

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 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: 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) and bhcg calibrator lot number jx33532.There were no other similar complaints found serial number (b)(4) during the searched period; there were three (3) similar complaints identified for bhcg calibrator lot number jx33532 during the searched period, which includes this event.This calibrator lot has been recalled due to poor stability of the calibrator set.The st aia-pack bhcg analyte application manual states the following: calibration.Calibration curve.The calibration curve for the st aia-pack bhcg 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).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.The most probable cause of the reported event was due to failure of the calibrator.

Event Description

A customer reported out of range high quality control (qc) results for beta human chorionic gonadotropin (bhcg) after calibration on the aia-900 analyzer.Prior to calling the technical support specialist (tss), the customer attempted recalibrating, but qc and patient sample results remained high.Tss sent a new calibrator to the customer; customer received the calibrator and recalibrated successfully; all qc results are in acceptable range.No further action required by tss.The aia-900 analyzer is functioning as expected.There was no indication of patient intervention or adverse health consequences due to the delay in reporting bhcg patient results.

• Brand Name: AIA-900
• Type of Device: AIA-900
• 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: 10420977
• MDR Text Key: 204763270
• Report Number: 8031673-2020-00237
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2015
• 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