MAUDE Adverse Event Report: BECKMAN COULTER ACCESS ESTRADIOL; RADIOIMMUNOASSAY, ESTRADIOL

Catalog Number	33540
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.The access estradiol 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 conjunction with this event.The patient's sample was sent to beckman coulter for interference testing.Interference testing results did not demonstrate the presence of patient-source heterophile (goat igg), alkaline phosphatase.In conclusion, the cause of this event cannot be determined with the available information.Beckman coulter internal identifier for this report is: (b)(4).
Event or Problem Description
On (b)(6) 2019, the customer reported obtaining reproducible low estradiol (access estradiol) results for one patient involving the laboratory's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4) on (b)(6) 2019.The sample was tested twice on the same analyzer; results obtained were 685 pg/ml (10:18 am) and 657 pg/ml (11:47 am).The customer did not provide a reference range.The beckman coulter access estradiol reference range is as follows: (b)(6) 2019.There was a report of change to patient treatment based on the results.The patient was administered ovidrel hcg.Customer reported subsequent egg retrieval was performed on (b)(6) 2019.Customer reported egg retrieval may have been performed too soon as physician noted some of patient's eggs were impacted.The customer subsequently reported that the patient is currently pregnant.System performance indicators such as system check, calibration and quality control were performing within specifications and did not indicate any issues with the system.No hardware errors were reported at the time of the event.Customer noted no issues with sample integrity.Sample was collected in 'gold top tube' and was a full draw.Customer stated centrifugation for 10-15 minutes but customer did not know centrifuge speed.

• Brand Name: ACCESS ESTRADIOL
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 9386132
• Report Number: 2122870-2019-01144
• Device Sequence Number: 2403377
• Product Code: CHP
• UDI-Device Identifier: 15099590231408
• UDI-Public: (01)15099590231408(17)200531(11)190601(10)920955
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K973743
• 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): 11/27/2019

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: 05/31/2020
• Device Catalogue Number: 33540
• Device Lot Number: 920955
• Distributor Facility Aware Date: 11/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/27/2019
• 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