MAUDE Adverse Event Report: TOSOH HI-TEC AIA-360

Model Number AIA-360

Device Problem Imprecision (1307)

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

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: investigation is currently in-progress.

Event Description

On (b)(6) 2017 a customer reported a false positive patient result on troponin (ctnl 2) with the aia-360 analyzer.The customer reported that initial troponin result was 1.7 ng/ml (assay range 0.06 - 115 ng/ml), which was reported out of the laboratory and questioned by the physician.Upon repeat the troponin result was 0.6 ng/ml.There is no indication of any patient intervention or adverse health consequences due to this event.

Manufacturer Narrative

Report source: under the above section "user facility" was incorrectly selected.The only report source is "health professional".

Event Description

N/a.

Manufacturer Narrative

(b)(4) per exemption number e2017013.Device evaluation by manufacturer: a field service engineer was dispatched to further investigate the reported issue.The fse found that the waste pump was worn and the waste tubing to the pump was collapsing, causing poor washing and poor troponin results.The fse replaced waste pump and tubing.The fse proceeded to run quality controls on troponin, which recovered within acceptable range.The aia-360 was working within specifications after completing the repair.A 13-month complaint history review and service history review for similar complaints was performed for the aia-360, serial number (b)(4), from 06-aug-2016 through 06-sep-2017.There were no other similar complaints identified during the searched period.The cardiac troponin i st aia-pack ctnl 2nd gen assay specifications under limitations of the procedure, page 8, states the following: 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 most probable cause of the reported event was due to defectives waste pump and waste tubing.

Event Description

N/a.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSOH HI-TEC; 1-37 fukugawa minami-machi; shunan-shi 746-0042, ja, ; JA
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (IMPORTER); 6000 shoreline court; suite 101; south san francisco CA 94080
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 6916553
• MDR Text Key: 88469186
• Report Number: 8031673-2017-00046
• Device Sequence Number: 0
• Product Code: MMI
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2018
• Distributor Facility Aware Date: 09/06/2017
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/09/2018
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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