MAUDE Adverse Event Report: BECKMAN COULTER ACCESS PSA; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Catalog Number 37200

Device Problem High Test Results (2457)

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

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

The full patient identifier is (b)(6).The customer did not provide patient demographics such patient date of birth, weight, ethnicity or race.The beckman psa reagent was not returned for evaluation.A beckman coulter laboratory support specialist was dispatched to the site to assess instrument and system performance.While onsite, the lss performed interference testing.Interference testing identified patient-sourced hama interferents in the patient sample.The likely cause of this event is patient-sourced interferents.Per the access psa instructions for use, part number a85067 n, "for assays employing antibodies, the possibility exists for interference by heterophile antibodies in the patient sample.Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e.G.Hama, that interfere with immunoassays.Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in patient samples.".

Event Description

On (b)(6) 2021 the customer reported an erroneous reproducible elevated psa (access psa, part number 37200 and lot number 124120) was generated on the customer's dxi (unicel dxi 800 access immunoassay analyzer, part number 973100 and serial number (b)(4)).The erroneous elevated result of >152 ng/ml was reported out of the laboratory.There was a report of change to patient treatment or management in connection with this event.The patient underwent a nmr scan and biopsy.It was not indicated whether a contrast dye was used during the nmr scan.17 days after the original result was obtained, the patient was redrawn and a psa test was performed on the customer's dxi.A result of >152 ng/ml was obtained.The patient sample was retested on a roche platform and a transcape platform; results of 2.3 ng/ml (roche) and 2.8 ng/ml (transcape) were obtained.The customer then retested the patient sample on the dxi using a dilution (dilution not provided) and obtained a value of 100.89 ng/ml which was reported to be discordant to the original value of >152 ng/ml.The customer believed the beckman psa results to be incorrect and performed a bioassay (details not provided).The patient was ultimately diagnosed with benign prostatic hyperplasia and not cancer.System performance indicators such as system check, calibration and quality control (qc) were passing within specifications at the time of the event.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.Sample collection and handling information such as sample type, volume drawn, centrifugation time and speed, and other information was not provided by the customer.A beckman coulter laboratory support specialist (lss) was dispatched to the site to assess system performance.

• Brand Name: ACCESS PSA
• Type of Device: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• 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: 12668560
• MDR Text Key: 277629528
• Report Number: 2122870-2021-00169
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 15099590224592
• UDI-Public: (01)15099590224592(17)220331(11)210331(10)124120
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K974816
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 37200
• Device Lot Number: 124120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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
• Patient Age: 67 YR