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

Model Number AIA-900

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inadequate or Insufficient Training (1643); Human Factors Issue (2948)

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

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Prior to analysis of aia-900 whole blood samples are manually diluted by 21 folds with the pretreatment solution and the diluted samples are incubated in an external heath block at 40 ¿ 2¿c for 20 ¿ 3 minutes.The analysis of pretreated samples should be done within 2 hours after completion of the pretreatment process.If the analysis cannot be done within 2 hours, the pretreated samples should be stored at 10 ¿c for up to 24 hours.The most likely cause of the reported event is due to operator error.Contact office - name/address (and manufacturing site for devices): (b)(4).

Event Description

On (b)(6)-2017 the customer reported that quality controls (qc) for sa1c were out of range high on the aia-900 for a few days.The customer was asked to repeat qcs using a newly calibrated pipettor and qcs were low.New lots of test cups and calibrator were provided and qc repeated, which were in range, but then patient samples were running low.When qc was repeated the next day was low again.Patient sample was 5.0% / 5.2% and it was expected to be greater than 8%.The customer performs multiple assays on an aia-900, all other assays are performing as expected, qc and calibration are within acceptable range.Additional training on how to process samples prior to placing samples on analyzer was provided to the customer.

Manufacturer Narrative

(b)(4) per exemption number e2017013.Device evaluation by manufacturer: a 13-month complaint history review and service history review for similar complaints was performed for the aia-900, serial number (b)(4), from 25-apr-2016 through 25-may-2017.There were no other similar complaints identified during the searched period.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.

Event Description

N/a.

Manufacturer Narrative

(b)(4) per exemption number e2017013.Device evaluation by manufacturer: investigation into this issue by tosoh has determined that the st aia-pack hba1c assay can potentially generate erroneously elevated or erroneously decreased hba1c patient results on the aia systems.The investigation confirmed inconsistent or unexpected variability of hba1c results when comparing tosoh's st aia-pack hba1c to alternative hba1c testing.Risk to health: a falsely elevated or falsely low hba1c result may not be easily recognized when there is no patient history or clinical picture, which would indicate that an incorrect test result was obtained.In current medical practice, single hba1c blood measurements are the primary indicator of the degree of sustained glycemic control and it is not current practice to corroborate a blood hba1c result on an alternative system.Device failure may be easily recognized given a patient history or clinical picture, which is not consistent with the reported result, which is most likely to occur under a rigorous and routine medical care or in a hospital setting, such as an intensive care unit, where intense clinical observation occurs.However, because hba1c levels are extensively used in the outpatient setting at wide time intervals as the single reliable test to monitor glycemic control, device failure is not easily recognized by the user in this setting.The american diabetes association (ada) recommends measurement of hba1c (typically 3-4 times per year for type 1 and poorly controlled type 2 diabetic patients, and 2 times per year for well-controlled type 2 diabetic patients) to determine whether a patient's glycemic metabolic control has remained continuously within the target range.Immediate health consequences of a falsely low or falsely normal hba1c result include the failure of the healthcare practitioner to recognize very poor and deteriorating glycemic control in known diabetics who are not yet in a state of ketoacidosis, with the resulting consequence of the subsequent development of life-threatening diabetic ketoacidosis.Long-range health consequences of falsely low or falsely normal hba1c levels include the failure to recognize and manage inadequate glycemic control with the consequences of long-range risks for both the individual patient and the public health.These risks of sustained poor glycemic control for the individual diabetic and the public health include the development of diabetic neuropathy (including amputation); retinopathy (including blindness); diabetic renal disease (including end stage renal failure and need for dialysis), and macro-vascular disease (including cardiovascular events).Immediate and long-term health consequences of falsely elevated hba1c levels include the unnecessary addition of potent glucose-lowering drugs or the unnecessary increase in drug dosage in known diabetics, with the risk of hypoglycemia, including the life-threatening risk of coma and loss of consciousness as well as other disabling symptoms of hypoglycemia.Health risks of falsely low levels also include the risk of failure to diagnose diabetes, as well as the risk of failure to diagnose patients at increased risk for diabetes (prediabetes).In order to prevent any risk to health, tosoh has taken the following actions: immediate actions to be taken by the customer immediately discontinue use of all lot numbers of the st aia-pack hba1c test and components.Immediately remove all st aia-pack hba1c test and components materials/kits from their inventory.Review the information provide by tosoh with the medical director and/or lab director.Immediately notify and forward this information to physicians who have received test results that had been provided by the recalled products over the past 6 months so that they may determine if follow-up testing is required (e.G.If the hba1c results they received did not match other patient data such as symptoms, results of other tests (typically blood glucose levels), or clinical impressions, or results which showed inconsistent test values) immediately identify an alternative test option for your hba1c testing needs.Tosoh is permanently removing the st aia-pack hba1c test and components from the market.

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: 6795442
• MDR Text Key: 82990229
• Report Number: 8031673-2017-00014
• Device Sequence Number: 1
• 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,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• 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: 04/04/2018
• Distributor Facility Aware Date: 05/12/2017
• Device Age: 17 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/04/2018
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3005529799-2/21/18-004-R
• Patient Sequence Number: 1