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

Model Number 33550

Device Problem High Test Results (2457)

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

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Full patient identifier is case-(b)(4).The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.The access progesterone reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.Repeated results of different samples from this patient were similar elevated on the access and the roche methodologies.No fault was found.The clinician finally suspected that the patient was self-medicating.In conclusion, the access progesterone patient results were correct.The available information did not reasonably suggest a reagent or instrument malfunction.Although customer suspects that the patient was self-medicating, the cause of the elevated results cannot be determined.

Event Description

On (b)(6) 2021 the customer reported questioning a high progesterone result for one patient involving the laboratory's unicel dxi 800 access immunoassay analyzer (serial number (b)(4)).On (b)(6) 2021, a patient sample was tested with one unexpected high progesterone result of 5.76 ng/ml.The customer reported that the patient was waiting for an ovulation induction and the doctor expected a low progesterone result (the progesterone result should be < 1 ng/ml).Moreover, previously on (b)(6) 2021 the progesterone patient result was at 0.19 ng/ml.The patient was redraw the same day and the new sample was retested with a similar progesterone result of 7.7 ng/ml which precluded the possibility of ovulation induction.On (b)(6) 2021, the sample was retested on the roche platform with a similar high result of 6.02 ng/ml.The customer canceled the ovulation induction and delayed the treatment to next physiological cycle.No hardware errors or other assay issues were reported in conjunction with this event.Qc was passing within the laboratory¿s established ranges.Calibration passed on 30apr2021 with reagent lot 922125 and calibrator lot 922326.No system check was provided.A beckman laboratory service specialist (lss) was dispatched to the customer site on 02jun2021 and did not identify anything that could contribute to this event.No issues with sample integrity were reported by the customer.No further information was provided.

• Brand Name: ACCESS PROGESTERONE REAGENT
• 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: 11958456
• MDR Text Key: 254922876
• Report Number: 2122870-2021-00080
• Device Sequence Number: 1
• Product Code: JLS
• UDI-Device Identifier: 15099590231378
• UDI-Public: (01)15099590231378(17)220228(11)200906(10)922125
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K931228
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 33550
• Device Catalogue Number: 33550
• Device Lot Number: 922125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/01/2021
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2020
• 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