MAUDE Adverse Event Report: BECKMAN COULTER ACCESS PROGESTERONE; 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 05/19/2021

Event Type  Injury  

Manufacturer Narrative

The full patient identifier for this event is (b)(6).The customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.The access progesterone reagent was not returned for evaluation.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.Additional data provided by customer included a 15-replicate progesterone precision study was performed using low level quality control; the precision study recovered within specifications.The customer reported samples were collected in serum separator tubes with gel.The access progesterone reagent instructions for use (document a34447 p, available on the beckman coulter website) specimen section states, ¿serum is the recommended sample.To avoid time related absorption, specimens should not be stored in collection vials with gel separators.¿ although the customer collected the samples in tubes containing gel, use error cannot be confirmed as the customer did not acknowledge the samples were stored in tubes with gel.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On 26may2021 the customer reported obtaining non-reproducible erroneous elevated progesterone (access progesterone, part number 33550, lot number 922679) results, generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(4)) on (b)(6) 2021.The elevated progesterone result of 1.329 ng/ml was reported out of the laboratory.The sample was repeat tested on the same access 2 instrument later the same day and a result of 0.515 ng/ml was obtained.There was a report of change to patient treatment or management in association with this event.The customer stated the patient had cryo-monitoring cycle cancelled.No further information was provided with regard to change to patient treatment or outcome.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.Sample was a bd [becton dickinson sst [serum separator] tube.Sample appeared to be normal.Sample was centrifuged at 3300 (units not provided) for 10-15 minutes.Other processing information such as sample clotting time, sample aliquotting and sample storage were not provided by customer.

Manufacturer Narrative

On 25june2021 the customer provided additional clarifying information regarding patient test results.Date of event: originally reported: (b)(6) 2021.Corrected to: (b)(6) 2021.Describe event or problem: originally reported: on (b)(6) 2021 the customer reported obtaining non-reproducible erroneous elevated progesterone (access progesterone, part number 33550, lot number 922679) results, generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(6)) on (b)(6) 2021.The elevated progesterone result of 1.329 ng/ml was reported out of the laboratory.The sample was repeat tested on the same access 2 instrument later the same day and a result of 0.515 ng/ml was obtained.Corrected to: on (b)(6) 2021 the customer reported obtaining non-reproducible erroneous elevated progesterone (access progesterone, part number 33550, lot number 922679) results, generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(6)) on (b)(6) 2021.The elevated progesterone result of 3.682 ng/ml was reported out of the laboratory.The sample was repeat tested on the same access 2 instrument later the same day and a result of 0.679 ng/ml was obtained.Relevant tests/laboratory data, including dates: originally reported: sample was tested for progesterone on 12april2021.Sample was tested on customer's access 2 immunoassay analyzer serial number (b)(6).Results: 1.329 ng/ml (09:29); 0.515 ng/ml (10:31).Corrected to: sample was tested for progesterone on 19april2021.Sample was tested on customer's access 2 immunoassay analyzer serial number (b)(6).3.682 ng/ml (10:20); 0.679 ng/ml (11:19).

Event Description

On (b)(6) 2021 the customer reported obtaining non-reproducible erroneous elevated progesterone (access progesterone, part number 33550, lot number 922679) results, generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(6)) on 19april2021.The elevated progesterone result of 3.682 ng/ml was reported out of the laboratory.The sample was repeat tested on the same access 2 instrument later the same day and a result of 0.679 ng/ml was obtained.

• Brand Name: ACCESS PROGESTERONE
• Type of Device: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12017262
• MDR Text Key: 267904739
• Report Number: 2122870-2021-00087
• Device Sequence Number: 1
• Product Code: JLS
• UDI-Device Identifier: 15099590231378
• UDI-Public: (01)15099590231378(17)220430(11)201106(10)922679
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 33550
• Device Catalogue Number: 33550
• Device Lot Number: 922679
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other