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

Model Number	33550
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Age or date of birth, weight and ethnicity: the customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.The access progesterone reagent was not returned for evaluation.No other patient results were called into question.No error messages or issues with other assays were reported in connection with the event.A laboratory solution specialist (lss) was dispatched on customer site.The lss run qc that passed.There were no reports of hardware interventions performs or hardware parts replaced.In conclusion, the cause of this event cannot be determined with the available information.There is malfunction as original result is discordant with one replicate measurement of the same specimen on another methodology and patient clinical file.
Event or Problem Description
On (b)(6) 2021 the customer reported obtaining false elevated progesterone (access progesterone) results for one patient under ivf (in vitro fertilization) treatment and involving the laboratory's unicel dxi 800 access immuno analyzer (serial number (b)(4)).On (b)(6) 2021, unexpected high progesterone results of 2 ng/ml and 1.92 ng/ml were generated for one patient sample, both results were beyond the value of 1.5 ng/ml that is the minimum customer value to perform the collection of the mature eggs from ovaries.Based on these access high results, the collection of the mature eggs from ovaries was finally performed.Unfortunately, the eggs maturity was insufficient.The patient sample was retested on a third platform (no further information was provided) with an acceptable lower progesterone result of 0.89 ng/ml which was accordant with the conclusion of eggs immaturity and discordant with the bec results.There was an incorrect management to the patient attributable to the output from the device in this event as the collection of the mature eggs from ovaries should not have been performed.No error messages or issues with other assays were reported in connection with the event.There were no reports of hardware interventions performs or hardware parts replaced.No qc was provided at the time of the event.Calibration passed on 22aug2021 using reagent lot 124652 and calibrator lot 922900.A laboratory solution specialist (lss) was dispatched on site on 06 and 07sep2021.The lss run qc that passed.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.There was no report of sample integrity issues.

• Brand Name: ACCESS PROGESTERONE
• Common Device Name: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12511634
• Report Number: 2122870-2021-00154
• Device Sequence Number: 11047602
• Product Code: JLS
• UDI-Device Identifier: 15099590231378
• UDI-Public: (01)15099590231378(17)220831(11)210309(10)124652
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K931228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 33550
• Device Catalogue Number: 33550
• Device Lot Number: 124652
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2021
• Initial Report FDA Received Date: 09/22/2021
• 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