MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Issue (2379); Low Readings (2460)

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

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: (b)(4).Device evaluation by manufacturer: no conclusion is yet available; investigation is currently in-process.Additional information is being requested to the customer.

Event Description

On (b)(6) 2017 a customer reported lower than expected free thyroxine (ft4) results on patient samples with the aia-900 instrument.The customer reported that their lab normal reference range for ft4 is 0.8 - 1.8 ng/dl instead of tosoh's reference ranges of 0.75 - 1.54 ng/dl.The technical support specialist suggested running the customer's data into the ep evaluator with 20 patient results and asked for the original ft4 correlation studies.There is no indication of any patient intervention or adverse health consequences due to this event.

Manufacturer Narrative

Device evaluation by manufacturer: no conclusion is yet available; investigation is currently in-process.Report source: under the above section "user facility" was incorrectly selected.The only report source is "health professional".

Event Description

N/a.

Manufacturer Narrative

Device evaluation by manufacturer: multiple attempts were made to obtain additional information from the customer without any success.The free thyroxine st aia-pack ft4 assay specifications under page 8, states the following: expected values: each laboratory should determine a reference interval which corresponds to the characteristics of the population being tested.As with all diagnostic procedures, clinical results must be interpreted with regard to concomitant medications administered to the patient.Reference ranges: the interval given here was determined in serum samples from 103 apparently healthy individuals.Reference interval = 0.75 - 1.54 ng/dl (9.68 - 19.9 pmol/l).A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4), from 20-sep-2016 through aware date 20-oct-2017.There were no other similar events identified during the searched period.The most probable cause of the reported low ft4 patient results is due to the customer using a higher reference range than the one specified by tosoh.Additional manufacturer narrative: tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, 105-8 623; JA 105-8623
• MDR Report Key: 7043778
• MDR Text Key: 93343552
• Report Number: 8031673-2017-00113
• Device Sequence Number: 0
• Product Code: CEC
• 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,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2018,05/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2018
• Distributor Facility Aware Date: 10/20/2017
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/08/2018
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 10/20/2017; 10/20/2017
• Supplement Dates FDA Received: 12/30/2017; 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1