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

Catalog Number	921789
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier for this report is (b)(6).The customer did not provide patient demographics such as age, date of birth, sex, height, 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.Although the customer's quality control was reported to be out of range at the time of the event, other system performance indicators such as calibration and system check were performing within specifications.There is insufficient evidence to reasonably suggest a reagent or hardware malfunction occurred in this event.In conclusion, the cause of this event cannot be determined with the information supplied.
Event or Problem Description
On (b)(6) the customer reported an erroneous elevated access progesterone result (part number 335550 and lot number 921789) was generated on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)) (patient result not provided).The erroneous elevated access progesterone result was reported out of the laboratory.The customer reported that due to the elevated progesterone result, the intrauterine insemination (iui) procedure scheduled for the patient was delayed (length of delay of procedure not provided).There was no further information provided regarding patient treatment or management.Although the customer reported their quality control level 2 was out of range at the time of the event, other system performance indicators such as system check and calibration were performing within specifications at the time of the event.There is insufficient information to reasonably suggest a malfunction; there was no report of systemic issues such as impact to other assays in connection with this event.Sample was collected in a becton dickinson (bd) 8 ml serum separator tube (sst) and was noted to be a clean sample.Customer stated sample was centrifuged for five minutes but did not provide centrifugation speed or temperature.No other sample processing information was provided.

• Brand Name: ACCESS PROGESTERONE
• Common Device Name: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 10463115
• Report Number: 2122870-2020-00074
• Device Sequence Number: 14072433
• Product Code: JLS
• UDI-Device Identifier: 15099590231378
• UDI-Public: (01)15099590231378(17)210731(11)200207(10)921789
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 921789
• Device Lot Number: 921789
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/27/2020
• 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