MAUDE Adverse Event Report: TOSHO CORPORATION AIA-360

Model Number AIA-360

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

The customer indicated that her qc recovery is much better since the specimen syringe clog error was resolved.The customer's qc and patient comparisons for ipth were all within acceptable limits.The customer has been sending out the ipth specimens since (b)(6) 2020, and has informed the technical support specialist (tss) that she will resume patient testing for ipth.The aia-360 analyzer is operating as intended.The st aia-pack ipth analyte application manual states the following: name and intended use st aia-pack intact pth is designed for in vitro diagnostic use only for the quantitative measurement of the levels of parathyroid hormone in human serum and edta plasma on specific tosoh aia system analyzers.Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.Summary and explanation of test parathyroid hormone (pth) is a polypeptide of 84 amino acids (mw 9800 daltons).Pth raises blood ionized calcium levels by promoting bone dissolution and releasing calcium phosphate from the bone to the extra cellular fluid through direct action on bone.Pth also promotes reabsorption of ionized calcium and depresses the renal reabsorption of phosphate through action on the renal tubular.Hence, pth is an important hormone to optimize calcium ion concentrations in the blood (1-3).Pth is rapidly metabolized in the liver and kidney primarily to biologically active n-terminal and biologically inactive c-terminal fragments with much longer half-lives.C-terminal fragments, excreted from the kidney, are grossly elevated in subjects with renal insufficiency (4-5).Intact pth assays accurately reflects pth-secretion kinetics due to less influence by declining renal function.(6-9) therefore, intact pth is an important marker to diagnose the diseases of the parathyroid gland and the kidney.For example, in hyperparathyroidism and secondary hyperparathyroidism pth is used to judge success or failure of surgery in the removal of malignant parathyroid gland, and to monitor postoperative recovery.Principle of the assay the st aia-pack intact pth is a two-site immunoenzymometric assay which is performed entirely in the aia-pack.Intact pth present in the test sample is bound with polyclonal antibody immobilized on magnetic beads and enzyme-labeled polyclonal antibody in the aia- pack.The magnetic beads are washed to remove unbound enzyme-labeled polyclonal antibody and are then incubated with a fluorogenic substrate 4-methylumbelliferyl phosphate (4mup).The amount of enzyme-labeled polyclonal antibody that binds to the beads is directly proportional to intact pth concentration in the test sample.A standard curve is constructed, and unknown sample concentrations are calculated using this curve.Material provided (st aia-pack intact pth, cat.No.025213) 5 trays x 20 test cups (st aia-pack intact pth test cup) plastic test cups containing lyophilized twelve magnetic beads coated with anti-pth goat polyclonal antibody and anti-pth goat polyclonal antibodies 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 intact parathyroid hormone analysis using the st aia-pack intact pth (cat.No.025213) 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 intact pth calibrator set 020313.Calibrator #1 0 pg/ml.Calibrator #2 15 pg/ml (approx.).Calibrator #3 50 pg/ml (approx.).Calibrator #4 200 pg/ml (approx.).Calibrator #5 800 pg/ml (approx.).Calibrator #6 2400 pg/ml (approx.).Aia-pack intact pth sample diluting solution 025513.Aia-pack intact pth control set 025413.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.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from (b)(6) 2019 through aware date (b)(6) 2020.There were three similar complaints including this one identified during the searched period.The most probable cause of the reported event could be due to the error 4017 specimen system error detected.

Event Description

The field service engineer (fse) had requested for the technical support department to contact the customer since the customer had reported that the intact parathyroid hormone (ipth) quality control (qc) is out low and she is sending out the ipth specimens to a reference lab.The technical support specialist (tss) sent customer mac qc, ipth calibrator and ipth qc per the request of the fse via email.This aia-360 analyzer had a preventative maintenance (pm) and decontamination performed in july.The fse had been in contact with the customer and had asked the customer to evaluate mac and tosoh ipth for a week.This caused a delay in reporting intact parathyroid hormone (ipth) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

The probable cause was a clogged specimen syringe.

Manufacturer Narrative

Correction: b1.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSHO CORPORATION; shiba-koen first building; 3-8-2 shiba-koen; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 10518230
• MDR Text Key: 207400794
• Report Number: 8031673-2020-00257
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1