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

Catalog Number 33550

Device Problem Incorrect Measurement (1383)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

Full patient identifier is case#: (b)(6).The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.The customer did not supply a progesterone lot number; therefore, expiration date and udi are unavailable.The customer did not supply a progesterone lot number; therefore, date of manufacture is unavailable.The access reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.A sample from the patient was forwarded to beckman coulter for investigative interference testing.The patient sample was first tested neat for the progesterone assay.The chaska chu (complaint handling unit) obtained a similar progesterone result as the customer.Then, a dilution testing was performed.Results did show the presence of interferences since the test results were not linear.Interference testing, using heterophile and alkaline phosphatase blocking agents was performed on the sample.Recovery was significantly reduced using the blocking agent (scavenger alp) for the progesterone assay.In conclusion, the likely cause of this event is the presence of a patient-source interferent.

Event Description

The customer reported erroneous progesterone (access progesterone, part number 33550 and lot number not provided) were generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number: (b)(4) results were generated for one patient.The result of 1.10 ng/ml was released from the laboratory.There was a report of change to patient management in connection with this event.On (b)(6), 2023, the customer reported the patient was unable to receive treatment because her progesterone values were not in the correct range.Two written attempts were made to obtain additional information regarding the delay in treatment.To date, no additional information has been provided.The customer reported the progesterone result of 1.10 ng/ml did not align with results generated from a different analyzer.Customer was unable to provide additional information regarding alternate methodology or other results obtained.No hardware errors or issues with other assays were reported in connection with this event.No other patient results were called into question.No quality control failures were reported.Other system performance information such as system check and calibration were not provided for review.Sample collection and processing information such as sample type, sample volume collected, centrifugation speed and time and other sample processing information was not provided.The customer requested interference testing to be performed by the beckman coulter complaint handling unit (chu) and a patient sample was forwarded to chu for testing.

• Brand Name: ACCESS PROGESTERONE
• Type of Device: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16655936
• MDR Text Key: 312434411
• Report Number: 2122870-2023-00069
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 33550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female