MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS SENSITIVE ESTRADIOL; RADIOIMMUNOASSAY, ESTRADIOL

Catalog Number	B84493
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier for this report is (b)(6).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access sensitive estradiol reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.There is insufficient evidence to suggest a reagent or hardware malfunction occurred in this event.In conclusion, the cause of this event cannot be determined with the information supplied.There are a total of 32 mdrs submitted for (b)(6).
Event or Problem Description
The customer questioned low sensitive estradiol (access sensitive estradiol) results which had been generated on the customer's dxi 800 access immunoassay system.The customer reported on 09july2020 that based on the questioned low sensitive estradiol result there was a delay in patient treatment; specifically, a delay in administering ivf (in-vitro fertilization) therapy medications of follitropin alfa (gonal-f) and menotropins (menopur).There was no additional report of change to patient treatment or management in association with this event.The customer reported testing one sample drawn from the patient.The sample was tested on two different days.System performance indicators such as quality control and calibrations were passing within specifications at the time of the event.Although the customer reported a failing system check, they reported a subsequent system check repeated the same day passed within specifications; there is insufficient information to reasonably suggest a malfunction; additionally, there were no reports of systemic issues such as impact to other assays in connection with this event.Sample was collected in a becton dickinson (bd) gel plasma tube.Information regarding tube manufacturer, tube sizes, volumes drawn, sample processing and centrifugation or other information was not provided.

• Brand Name: ACCESS SENSITIVE ESTRADIOL
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• MDR Report Key: 10349298
• Report Number: 9680746-2020-00031
• Device Sequence Number: 2617303
• Product Code: CHP
• UDI-Device Identifier: 15099590699383
• UDI-Public: (01)15099590699383(17)201028(11)191029(10)971122
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K023764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2020
• Device Catalogue Number: B84493
• Device Lot Number: 971122
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other