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 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2017, the technical support specialist (tss) conducted troubleshooting with the customer over-the-phone to address the reported event.The customer stated the qc was made a day prior to the reported event and the instrument was calibrated on (b)(6) 2017.There was no rate data on the qa spreadsheet.The customer stated a field service engineer is scheduled on 21-mar-2017 he will decontaminate the reagent lines.The customer requests to wait to troubleshoot after the service call.No further action required from tss.On 20-mar-2017, an fse was on-site for service call.The ala-900 analyzer is functioning as intended with all issues cleared.No further action required by fse.The most probable cause of the reported event was unknown.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).

Event Description

On (b)(6) 2017, a customer reported st hba1c qc is running high with the aia-900 analyzer.The customer is unable to run hba1c patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7421737
• MDR Text Key: 105535572
• Report Number: 8031673-2018-05054
• Device Sequence Number: 0
• Product Code: LCP
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/11/2018

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2018
• Distributor Facility Aware Date: 03/16/2017
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/11/2018
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2016
• 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