MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number 022930111

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the reported issue by reviewing the customer's control results.The fse was able to reproduce the reported event by running controls.The fse reviewed the decontamination procedure the customer was using and found that they were doing the decontamination procedure for regular maintenance.This procedure does not include the substrate line.The fse decontaminated the system, including the substrate line.The fse also ran fsh controls and there was a shift in results.The customer calibrated fsh and the fse followed up with them to see if the controls stayed in range.The fsh controls have stayed in range.The analyzer has been returned to normal use by the customer.The aia-900 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 24may2019 through aware date (b)(6) 2020.There was one similar complaint identified during the searched period.Follicle stimulating hormone st aia-pack fsh: name and intended use st aia-pack fsh is designed for in vitro diagnostic use only for the quantitative measurement of follicle-stimulating hormone (fsh) in human serum or heparinized plasma on specific tosoh aia system analyzers.Summary and explanation of test follicle-stimulating hormone (fsh) is a glycoprotein which, like lh, hcg and tsh consists of alpha and beta chains.The alpha chain is virtually identical in all four hormones, whereas the beta chains are different and determine both the specific biological activity and immunological characteristics of each hormone.1,2 the fsh molecule contains approximately 16% carbohydrate and has a molecular weight of approximately 28,000 to 30,000 daltons.3 fsh stimulates ovarian follicle growth and estrogen production in women, and testicular spermatogenesis in men.4-7 hypothalamic control of both fsh and lh secretion by the anterior pituitary appears to be by a common releasing hormone, gonadotropin-releasing hormone (gnrh) with negative feed back at the hypothalamic level by estrogen in the female and testosterone in the male.Determination of fsh concentrations is essential in assessment and monitoring of patients with suspected infertility.Other physiological disorders associated with abnormal fsh secretion have been reported.3,8-11 principle of the assay the st aia-pack fsh is a two-site immunoenzymometric assay which is performed entirely in the aia-pack.Fsh present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the aia-pack.The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate 4-methylumbelliferyl phosphate (4mup).The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the fsh concentration in the test sample.A standard curve is constructed and unknown sample concentrations are calculated using this curve.Material provided (aia-pack fsh, cat.No.025265) 5 trays x 20 test cups (st aia-pack fsh test cup) plastic test cups containing lyophilized magnetic beads coated with anti-fsh mouse monoclonal antibody and mouse monoclonal antibody (to human fsh) conjugated to bovine alkaline phosphatase with 0.1% sodium azide as a preservative.Materials required but not provided the following materials are not provided but are required to perform follicle-stimulating hormone analysis using the st aia-pack fsh (cat.No.025265) on specific tosoh aia systems.They are available separately from tosoh.Materials cat.No.Aia-systems: aia-360 019945 aia-600ii 019014 aia-600ii bcr 019328 aia-900 022930 aia-900 9tray sorter 022931 aia-900 19tray sorter 022932 aia-1800 st 019836 aia-1800 la 019837 aia-2000 st 022100 aia-2000 la 022101 aia-pack: aia-pack substrate set ii 020968 aia-pack substrate/reconstituent aia-pack fsh calibrator set 020365 calibrator zero 0 miu/ml positive 100 miu/ml (approx.) aia-pack fsh sample diluting solution 020565 aia-pack wash concentrate set 020955 aia-pack diluent concentrate set 020956 aia-pack detector standardization test cups 020970 aia-pack sample treatment cups 020971 sample cups 018581 additional requirements: (except aia-360) pipette tips (1000/pkg) 019215 tip rack (empty) 019216 preloaded pipette tips (96 tips x 50 racks) 996010 preloaded pipette tips (96 tips x 5 racks) 996005 only materials obtained from tosoh should be used.Materials obtained elsewhere should not be substituted since assay performance is based strictly on tosoh materials.The most probable cause of the reported event was decontamination needed, including the substrate line.

Event Description

Customer reported a continuing issue related to follicle stimulating hormone (fsh) quality control (qc) recovery.On the previous issue, the customer had performed analyzer decontamination and made fresh solutions and that was the resolution to bringing the qc for fsh back into normal range.Currently, the customer indicated that since that time, the fsh only was climbing high out of range.The technical support specialist (tss) asked the customer if they could have possibly ran a different pack lot of fsh as compared to calibration from the other time and customer indicated no and that was not the case.The tss also asked if a different wash or diluent was used currently as compared to the last time and the answer was also no.The customer again stated that the issue is only related to fsh.The tss requested for customer to make fresh wash and diluent solutions and prime six times for both wash and diluent, then verify the fsh pack lot number being used and to ensure that the pack lot used is the same lot that was calibrated the last time and to re-run with a different freshly made qc.The customer had called back the following day to report that with the fresh qc material, fresh wash and diluent the fsh qc results were still recovering low.Due to the continuing fsh issues, the customer requested onsite service.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting follicle stimulating hormone (fsh) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10405466
• MDR Text Key: 229186761
• Report Number: 8031673-2020-00188
• Device Sequence Number: 1
• Product Code: KHO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 022930111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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