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

Model Number	33550
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11958456
• Report Number: 2122870-2021-00080
• Device Sequence Number: 19162862
• Product Code: JLS
• UDI-Device Identifier: 15099590231378
• UDI-Public: (01)15099590231378(17)220228(11)200906(10)922125
• 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): 06/08/2021

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?: No
• Operator of Device: 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
• Distributor Facility Aware Date: 06/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/08/2021
• 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