MAUDE Adverse Event Report: BECKMAN COULTER IRELAND ACCESS HFSH REAGENT; RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

Catalog Number 33520

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 09/22/2016

Event Type  Injury  

Manufacturer Narrative

The customer did not supply patient's date of birth and weight.There is no evidence that the access hfsh reagent was returned for evaluation.A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site.The customer was advised to send the patient's sample to the beckman coulter complaint handling unit (chu) for evaluation.The marseilles chu received one (1) sample for investigation.The patient's sample was analyzed utilizing the access hfsh assay on the access 2 immunoassay system (serial number (b)(4)).The marseilles chu obtained one (1) elevated result and confirmed customer's results.Further testing of this sample, with blocker proteins, decreased the sample's signal causing a decrease in the access hfsh result by 66%, confirming the presence of a patient source interferent related to heterophile antibodies.In conclusion, the cause of the elevated access hfsh results is due to a patient source interferent related to heterophile antibodies.

Event Description

The customer reported obtaining repeatable elevated follicle stimulating hormone (access hfsh) results for one (1) patient involving the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) that were discordant to the patient's clinical file.The initial access hfsh result recovered above the assay's normal reference range.The customer reanalyzed the patient's sample several additional times (no precision provided) on the same laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) and obtained elevated results recovering above the assay's normal reference range again.Due to these elevated access hfsh results, the patient underwent a stimulation test.There was no report of additional change to treatment in conjunction with this event.Calibrations, quality controls (qc) and system checks were performing within assay and instrument specifications.No hardware errors, flags or other assay issues were reported in conjunction with this event.The patient's sample was collected in a serum tube and was centrifuged at 3,000 rpm (rotations per minute) for ten (10) minutes at room temperature.No issues with sample integrity were reported by the customer.

• Brand Name: ACCESS HFSH REAGENT
• Type of Device: RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE
• Manufacturer (Section D): BECKMAN COULTER IRELAND; mervue business park; mervue, galway, ; EI
• Manufacturer (Section G): BECKMAN COULTER IRELAND; mervue business park; mervue, galway, ; EI
• Manufacturer Contact: angela kilian ; 1000 lake hazeltine drive; chaska 55318 ; 9523681330
• MDR Report Key: 6043693
• MDR Text Key: 57973201
• Report Number: 9680746-2016-00004
• Device Sequence Number: 1
• Product Code: CGJ
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)170430(11)NO-DATA(10)623241
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K940005
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 33520
• Device Lot Number: 570257
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR