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	Insufficient Information (4580)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is (b)(6).The customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.The access snse2 reagent was not returned for evaluation.All assay and system verifications met specifications at the time of the event.No hardware errors, flags or other assay issues were reported in connection with this event.Although the customer was expecting an increase in estradiol results, the customer was unable to provide the expected range of results for the individual methods used.No information has been provided regarding any specific medication taken by the patient in this event.In conclusion, an assignable cause of the event cannot be determined with the available information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.Note: two (2) medwatch reports will be generated to address customer reports of delay to treatment for two different patients.This report will address patient one: (b)(4).
Event or Problem Description
On 10mar2023 the customer reported obtaining false low sensitive estradiol (access snse2) results for two patient samples involving the laboratory's dxi 800 access immunoassay w/spot b analyzer (serial number (b)(4)).The results were questioned as not meeting the clinical presentation of the patients.The patients were reported to be undergoing egg stimulation (ivf) and higher estradiol results were expected.Two (2) medwatch reports will be generated to address customer reports of delay to treatment for two different patients.This report will address patient one.On (b)(6) 2023, the questioned snse2 patient 1 sample results were at 877.11 pg/ml, repeated at 919.02 pg/ml and at 945.78 pg/ml.The results were also questioned as an snse2 result of 1052.98 pg/ml was previously obtained after an ivf injection.An increase in snse2 recovery was expected when running a new sample from the patient on (b)(6) 2023.The sample questioned was run on an alternate instrument platform (roche cobas) and a higher result was obtained at 3077 pg/ml.Range of results expected on the alternate instrument platform was not specified in this event.On 26mar2023, the customer reported ivf (in vitro fertilization) treatment was delayed in connection with the low snse2 results.The customer reported the treatment was delayed as the laboratory was waiting for results from the alternate site.No hardware errors or issues with other assays were reported in conjunction with this event.No calibration data was provided.A passing unwashed system check was obtained on 09mar2023.Quality control was reported to recover within range in connection with the event.Sample tube collection type was not provided.The customer reported that the sample was centrifuged for 10 minutes at 3000 rpm [revolutions per minute].There was no report of sample integrity issues.No further sample information was provided.

• Brand Name: ACCESS SENSITIVE ESTRADIOL
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer (Section G): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16699168
• Report Number: 9680746-2023-00005
• Device Sequence Number: 3628713
• Product Code: CHP
• UDI-Device Identifier: 15099590699383
• UDI-Public: (01)15099590699383(17)230823(11)220823(10)272173
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2023

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: 08/23/2023
• Device Catalogue Number: B84493
• Device Lot Number: 272173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female