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

Catalog Number	33540
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access estradiol reagent was not returned for evaluation.The initial patient results and the repeat lower patient results were run on the same calibration curve.Two reagent pack serial numbers were in use, but did not coincide with the high verses low patient results.Other assays were run during the time of this event.The results were not questioned by the customer.In conclusion there is no evidence to reasonably suggest a system malfunction.There were no hardware errors or other assay issues reported in conjunction with this event.System checks, calibration and precision studies met assay and instrument specifications.An assignable cause for this event could not be determined with the information provided.
Event or Problem Description
The customer reported obtaining non-reproducible elevated estradiol (access estradiol) results for twelve patients involving the laboratory's access 2 immunoassay system (serial number (b)(4)).Later the same day, the customer reanalyzed the patients' samples on the same access 2 immunoassay system and obtained lower results.The initial results were released from the laboratory and questioned by the physician.The doctor informed the laboratory technician that some of the decisions would have been different for some of these patients due to the higher estradiol results but all would have been related to medication dosages and not procedures or harm.It is not clear if changes to medication dosage actually occurred or if the doctor was speculating that dosage changes were possible with the change in estradiol results.The number of patients that may have had a change to treatment was not provided.The patient reports were corrected to the lower result the same day.Calibration and system check were performing within assay and instrument specifications at the time of the event.Quality control was stated to be within the customer's ranges, but upon evaluation level one and two recovered above the customer's 2 sd (standard deviation) range and level three recovered below 2 sd.There were no hardware errors or other assay issues reported in conjunction with this event.The samples were collected in serum tubes.Information on sample processing and centrifugation such as speed, time and temperature was not provided.No issues with sample integrity were reported.
Additional Manufacturer Narrative
Further information was received from the customer on april 11, 2018.The following information was provided: ·there was no change to treatment in this event.No changes were made to the patient's medication dosages due to the elevated access estradiol results.·the access 2 immunoassay system and assay are currently performing within the customer's expectations.In conclusion: there was no malfunction or adverse event in conjunction with this event.

• Brand Name: ACCESS ESTRADIOL REAGENT
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 7361278
• Report Number: 2122870-2018-00020
• Device Sequence Number: 172969
• Product Code: CHP
• UDI-Device Identifier: 15099590231408
• UDI-Public: (01)15099590231408(17)180630(11)170722(10)723820
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: 955769
• 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,Followup
• Report Date (Section B): 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 33540
• Device Lot Number: 723820
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/18/2018
• 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