MAUDE Adverse Event Report: TOSOH HI-TEC AIA-900

Model Number AIA-900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted late because of difficulties setting up the user account through the electronic submissions gateway (esg) system.Contact office - name/address (and manufacturing site for devices): (b)(4).

Event Description

On (b)(6)2017 customer reported quality control (qc) was lower than expected and lower folate results were also seen with 7 patient samples.Customer repeated calibration, which increased the patients' results.Normal range for folate is 3 - 16 ng/ml: pre-calibration patient 1 = 2.42 ng/ml / post-calibration 3.13 ng/ml.Pre-calibration patient 2 = 3.56 ng/ml / post-calibration 4.44 ng/ml.Pre-calibration patient 3 = 5.19 ng/ml / post-calibration 6.32 ng/ml.Pre-calibration patient 4 = 18.69 ng/ml / post-calibration >20.0 ng/ml*.Pre-calibration patient 5 = 6.24 ng/ml / post-calibration 7.3 ng/ml pre-calibration patient 6 = 14.63 ng/ml / post-calibration 17.1 ng/ml*.Pre-calibration patient 7 = 3.14 ng/ml / post-calibration 3.96 ng/ml.* these patient results were inside the acceptable range prior to recalibration.The customer reported that although results changed, there was no modification to any of the patients' treatment plan.A contributing factor to the reported issue by the customer was most likely a minor lot to lot variability.The aia-900 is performing as designed.

Manufacturer Narrative

Device evaluation by manufacturer: a 13-month complaint history review and service history review for similar complaints was performed for the aia-360, serial number (b)(4), from 27-may-2016 through 27-jun-2017.There were no other similar complaints identified during the searched period.The aia-pack folate assay specifications, under 3) calibration, page 6, states: the calibration curve for the aia-pack folate is stable for up to 30 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).Recalibration is necessary if there is a change in the lot number of the folate pretreatment set.For further information regarding instrument operation, consult the aia system operator's manual.Evaluation of results, quality control, page 9, states: 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, three levels of controls are run in order to accept the calibration curve.· the three 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.Standard laboratory procedures should be followed in accordance with the regulatory agency under which the laboratory operates.Report source: under the above section "user facility" was incorrectly selected.The only report source is "health professional".

Event Description

N/a.

• Brand Name: AIA-900
• Type of Device: AIA-900
• 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: 6793417
• MDR Text Key: 83099629
• Report Number: 8031673-2017-00009
• Device Sequence Number: 0
• Product Code: CGN
• 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
• Report Date: 12/28/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2017
• Distributor Facility Aware Date: 06/27/2017
• Device Age: 9 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/28/2017
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2008
• 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