MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

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

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

Event Date 10/26/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at customer's site to resolve reported event.Fse resolved the reported issue by replacing the substrate 3-way valve and wash system 3-way valve.No further action required by field service.The aia-900 analyzer is functioning as expected.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 were no similar complaints identified during the search period.The st aia-pack troponin i ctnl2 analyte application manual states the following: limitations of the procedure for diagnostic purposes, the results obtained from this assay should be used in conjunction with other data (e.G., symptoms, results of other tests, clinical impressions, therapy, etc.).Troponin i results should never be used as the single determining factor in treatment of the patient.Physicians should be made aware that published literature indicates possible interference in troponin i assays - i.E.Both false positive and false negative results.16, 17 studies on patients diagnosed with myocarditis and dilated cardiomyopathy indicate that disease specific cardiac autoantibodies may be present in the serum and plasma of these and other patients.18-20 autoantibodies are generated against cardiac proteins and this could potentially cause false negative results if the autoantibodies produced interfere with the epitopes utilized in a particular manufacturer's assay.Results from this or any other in vitro diagnostic procedure which do not correlate with the clinical presentation of the patient should be interpreted with extreme caution.The use of a single ctni result on a patient should be discouraged.As with the other cardiac markers, a temporal pattern of rise and fall over time should be observed to aid in accurate interpretation of the results.Users are reminded that elevations in ctni can occur for reasons other than myocardial infarction, and lack of a ctni value over a certain value does not preclude ami or serious cardiac injury.Assays from various manufacturers may yield different results.Reactivity of the epitopes used in the assay vary with the form of ctni present in a specific specimen.Also, assay calibration between manufacturers is not standardized.Using st aia-pack ctni 2nd-gen, the highest concentration of troponin i measurable without dilution is approximately 115 ng/ml, and the lowest measurable concentration is 0.06 ng/ml (assay sensitivity).Although the approximate value of the highest calibrator is 115 ng/ml, the exact concentration may be slightly different.The assay specification, assay range high, should be defined as the upper limit of the assay range, 115 ng/ml.Although hemolysis has an insignificant effect on the assay, hemolyzed samples may indicate mistreatment of a specimen prior to assay and results should be interpreted with caution.The most probable cause of the reported event is due to faulty substrate and wash system 3-way valves.

Event Description

A customer reported getting possible imprecision of cardiac troponin i (ctnl2) results during sample runs with the aia-900 analyzer.The customer reported initial run result was positive but when run was repeated, the result was <0.06ng/ml which was closer to the patient's clinical history.The customer ran a 10-replicate precision study and all controls were reported to be within acceptable ranges.The customer insisted on onsite service to inspect the wash probes.A field service engineer was dispatched to address the reported event.There is no indication of any patient intervention or adverse health consequences due to the discrepant 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: 9366268
• MDR Text Key: 220571031
• Report Number: 8031673-2019-00472
• 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: 11/22/2019

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-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2019
• Initial Date FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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