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

Catalog Number 33550

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

Full patient identifier is case- (b)(6).Reagent lot number was not provided; therefore, a lot manufacture date could not be obtained.The access progesterone reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.A beckman coulter laboratory support specialist (lss) was dispatched to the customer site; the lss performed interference testing on the sample.Lss testing of the neat sample produced an elevated result that confirmed the customer's result.Interference testing including alkaline phosphatase blockers and goat igg was performed.Result recovery was significantly reduced using the alkaline phosphatase blockers and the goat igg.The presence of a patient-source interferent related to alkaline phosphatase and goat igg was confirmed.(b)(4).In conclusion, the cause of this event is due to confirmed patient-sourced interferents.

Event Description

On (b)(6) 2020 the customer reported that erroneous reproducible elevated progesterone results (access progesterone, part number 33550) had been generated on the customer's dxi 800 access immunoassay system (part number 973100 and serial number (b)(4)).The customer reported that these results were discordant to the patient's clinical presentation and ultrasound findings.The customer also reported that based on the reproducible elevated progesterone results, there was a delay in patient treatment; specifically, a deferral of embryo transplantation.There was no additional report of change to patient treatment or management in association with this event.System performance indicators such as system check, quality control and calibration were all passing within specifications at the time of the event.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.A beckman coulter laboratory support specialist (lss) was dispatched to the customer site to assess the system; lss did not note any system issues.While onsite the lss performed interference testing.The lss initially performed testing on the neat sample and obtained elevated results, confirming the customer's test result.The lss then performed serial dilutions which showed a linear slope.The lss then performed interference testing using alkaline phosphatase blockers and goat igg.The interference testing showed significant decrease in signal when both blockers were used, indicating the presence of interferents in the patient's sample.Sample collection and processing information such as sample type, tube manufacturer, sample handling conditions, centrifugation and other sample processing information was not provided.

• 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: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 10574323
• MDR Text Key: 208165053
• Report Number: 2122870-2020-00083
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 33550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2020
• 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