MAUDE Adverse Event Report: TOSOH CORPORATION ST AIA-PACK ESTRADIOL ASSAY

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Output Problem (3005)

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

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

The technical support specialist (tss) followed up with the customer a week later, and customer indicated that the quality control is now in range, and the aia-360 analyzer is performing as expected.The qc data was not provided.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 23sep2020.There were two similar complaints including this one identified during the searched period.Name and intended use: st aia-pack e2 is designed for in vitro diagnostic use only for the quantitative measurement of estradiol (e2) in human serum and heparinized plasma on specific tosoh aia system analyzers.Summary and explanation of test: estradiol (1,3,5(10)-estratriene-3, 17ss-diol; e2) is a steroid hormone produced mainly by the ovary in females and, in lesser amounts, by the testes in males.1 in non-pregnant subjects there is cyclic variation in the concentration of e2 with the highest concentrations occurring just prior to ovulation.2,3 in the first half of the menstrual cycle, follicle stimulating hormone (fsh) accelerates follicular development and e2 secretion.Rapid secretion of e2 imposes a positive feedback influence upon the pituitary gland, resulting in the release of luteinizing hormone (lh) from the pituitary, and ovulation begins.The measurement of e2 simultaneously with fsh and lh levels can provide information to evaluate ovary function.5 in males, e2 measurements are used for investigating feminizing syndromes such as gynaecomastia.6 principle of the assay; the st aia-pack e2 is a competitive enzyme immunoassay which is performed entirely within the aia-pack.Estradiol present in the test sample competes with enzyme-labeled estradiol for a limited number of binding sites on a estradiol-specific antibody immobilized on magnetic beads.The beads are washed to remove the unbound enzyme labeled estradiol and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4mup).The amount of enzyme labeled estradiol that binds to the beads is inversely proportional to the estradiol concentration in the test sample.A standard curve using a range of known standard concentrations is constructed and unknown estradiol concentrations are calculated using this curve.Material provided (st aia-pack e2, cat.No.025274); 5 trays x 20 test cups (st aia-pack e2 test cup); plastic test cups containing lyophilized magnetic beads with anti-e2 rabbit polyclonal antibody and estradiol conjugated to bovine alkaline phosphatase with 0.1% sodium azide as a preservative.The most probable cause of the reported event is normal lot-to-lot variation.Submission of this report does not constitute an admission that the manufacturer's product caused, or contributed to the event.

Event Description

Customer reported that the e2 controls are out high following change to new estradiol (e2) test cup lot.Multiple calibrations have been performed.The decontamination was performed recently.No other assays are affected.The customer was sent a different e2 test cup, and will follow up with technical support.The aia-360 analyzer is not down.The customer had contacted technical support a few days later to inform them the wrong calibrator was received so the technical support specialist (tss) sent customer another e2 calibrator.This caused a delay in reporting estradiol (e2) patient samples.There was no indication of any patient intervention, or adverse health consequences due to the delay in reporting of patient results.The tss followed up with the customer a week later, and customer indicated that the quality control is now in range and the aia-360 analyzer is performing as expected.The qc data was not provided.

• Brand Name: ST AIA-PACK ESTRADIOL ASSAY
• Type of Device: ST AIA-PACK ESTRADIOL ASSAY
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 10717968
• MDR Text Key: 215036836
• Report Number: 8031673-2020-00307
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• PMA/PMN Number: K023091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 025204
• Device Lot Number: A312953
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1