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

Catalog Number 37200

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/09/2015

Event Type  malfunction  

Event Description

The customer reported a lower than expected prostate-specific antigen (access hybritech psa) result for one (1) patient on the access 2 immunoassay system (serial number (b)(4)).The physician questioned the initial result as the patient was known to have previously elevated access hybritech psa results.On (b)(6) 2015 the patient's prostate-specific antigen (psa) was tested at a reference laboratory (quest diagnostics) on an alternate methodology (siemens) and a higher result above the normal reference range was obtained.The customer stated the initial access hybritech psa result was reported outside the laboratory.There was no report of patient injury or change in patient treatment associated with this event.The customer noted that quality control (qc), assay calibration, a precision test and system check were performing within specifications at the time of the event.The patient's sample was collected in a serum tube and analyzed from a 2ml sample cup.The sample was centrifuged at 3,250 rpm (revolutions per minute) for ten (10) minutes at room temperature.The customer did not report any issues with sample integrity.

Manufacturer Narrative

The customer did not supply demographic for the patient such as the exact date of birth and weight.Service was not dispatched.There is no evidence that the access hybritech psa reagent was returned for evaluation.In conclusion, the cause of the event cannot be determined with the available information.

• Brand Name: ACCESS HYBRITECH PSA REAGENT
• 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: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 4511994
• MDR Text Key: 5404390
• Report Number: 2122870-2015-00101
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 37200
• Device Lot Number: 430121
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• 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 Age: 74 YR