MAUDE Adverse Event Report: BECKMAN COULTER ACCESS HYBRITECH PSA REAGENT; TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED), PRODUCT CODE: MTF

Catalog Number 37200

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide patient demographics such as age, date of birth, sex or weight.Service was not dispatched for this event.There is no indication that the access hybritech psa reagent was returned for evaluation.In conclusion, an assignable cause of the non-reproducibly false low access hybritech psa result is unknown and cannot be determined with the available information.

Event Description

On (b)(6) 2015, the customer reported one (1) non-reproducibly false low prostate-specific antigen (access hybritech psa) result which was obtained on the laboratory's unicel dxi 600 access immunoassay system (serial number (b)(4)) for one (1) patient.The initial access hybritech psa result of 82.069 ng/ml was reported outside of the laboratory.The lab technician questioned the result and the same sample was repeated eight (8) times on the same unicel dxi 600 access immunoassay system.The repeated results recovered reproducibly high with results of 128.2 ng/ml, 132.691 ng/ml, 143.183 ng/ml, 142.8 ng/ml, 137.595 ng/ml, 139.784 ng/ml, 142.48 ng/ml and 135.734 ng/ml obtained.There were no reports of patient injury or change to patient treatment associated with this event.Calibration prior to this event was passing assay specifications.One level of quality control (qc) was running out of the customer's established range on the date of event.A system check performed after this event was passing within instrument specifications.There were no errors posted in the event log.Two (2) precision studies were performed using level 3 qc.The precision studies met assay and system specifications.The sample was collected in a becton dickinson (bd) serum gold top tube on (b)(6) 2015 and was centrifuged at 3000 revolutions per minute (rpm) for 10 minutes at room temperature.The sample was stored refrigerated until it was tested on (b)(6) 2015.The customer noted no sample integrity issues.

• Brand Name: ACCESS HYBRITECH PSA REAGENT
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED), PRODUCT CODE: MTF
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer Contact: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5274517
• MDR Text Key: 32983654
• Report Number: 2122870-2015-00835
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: H628372001
• UDI-Public: H628372001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 37200
• Device Lot Number: 529568
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2015
• 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