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

Catalog Number	33550
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.No hardware errors or other assay issues were reported in conjunction with this event by the customer.The instrument is correctly maintained by the customer.No issues with sample integrity were reported by the customer.Calibration passed on 20may2019.Qc was passing within the laboratory¿s established ranges at the time of the event.Per the progesterone instructions for use, part number: a34447 m, the range of observations for non-pregnant females in the mid-follicular phase is 0.31-1.52 ng/ml.The progesterone reagent was not returned for evaluation.The cause of this incident cannot be determined with the available information.The beckman coulter internal identifier for this event is case-(b)(4).
Event or Problem Description
The customer reported obtaining erroneously elevated progesterone patient results on their unicel dxi 800 access immunoassay system (s/n: (b)(4)).The customers patient results were higher than the normal range of the assay.Results were also discordant with the roche method.No further information was provided on the roche method.There was a change in patient treatment.Some patients (number unknown) were treated based upon the elevated access progesterone results.Gnrh antagonist was given to those patients under ivf procedure to lower their progesterone level.The duration of the treatment varied between 10-15 days and the embryo transfer may be one month delayed.There was no further report of change to treatment nor any other adverse effect reported.

• Brand Name: ACCESS PROGESTERONE
• Common Device Name: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821 8000
• MDR Report Key: 8674230
• Report Number: 2122870-2019-01082
• Device Sequence Number: 334902
• Product Code: JLS
• UDI-Device Identifier: 15099590231378
• UDI-Public: (01)15099590231378(17)200430(11)20200430(10)832149
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K955769
• 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): 06/06/2019

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: 04/30/2020
• Device Catalogue Number: 33550
• Device Lot Number: 832149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other