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

Catalog Number 33520

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, weight, ethnicity: the customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.Device evaluated by mfr: the access hfsh reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.The customer performed linear dilution testing on the patient's sample and obtained non-linear results suggesting a patient-source interferent.In addition, the customer sent sample to a reference laboratory who pre-treated the sample with blocking agents.The result obtained was significantly lower than the customer's result again suggesting the presence of a patient-source interferent of unknown origin.In conclusion, the cause of this event is due to an unknown patient-source interferent.

Event Description

The customer contacted beckman coulter (bci) to report obtaining a higher than expected follicle stimulating hormone (access hfsh) result for one female patient on the laboratory¿s access 2 immunoassay analyzer serial number (b)(4).The first access hfsh result questioned was on (b)(6) 2019.The customer took the patient off of their birth-control medication at this time.Another sample was collected and tested for access hfsh again; another higher than expected result was obtained.The customer performed linear dilutions and noted that the results obtained were not linear suggesting that a patient-source interferent was present.The patient then had an mri (magnetic resonance imaging) of the head performed which was normal (it is unknown if contrast dye was used).In addition, the patient received treatment with a gnrh (gonadotropin-releasing hormone) antagonist, however, the access hfsh result was still higher than expected.On (b)(6) 2019 a third sample was tested for the access hfsh assay and the result was similar; still elevated.This sample was also sent to a reference laboratory which used a different methodology (type unknown) and pretreatment with a blocking reagent.The result was much lower than the access hfsh result and more in-line with the customer¿s expectation based upon the patient¿s clinical presentation.There was a change in patient care/management as the patient was taken off of their birth-control medication, underwent an mri of the head and was treated with a gnrh antagonist.There was no report of injury or death associated with this event.The customer did not provide any information as to the instrument¿s performance including qc (quality control), calibrations or system check.However, there were no reports of issues with hardware or other patient results or assays.Sample collection and preparation information was not supplied including sample type, centrifugation time and speed and storage conditions.

• Brand Name: ACCESS HFSH REAGENT
• Type of Device: RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE
• 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: david davis ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8524260
• MDR Text Key: 142262806
• Report Number: 2122870-2019-01070
• Device Sequence Number: 1
• Product Code: CGJ
• UDI-Device Identifier: 15099590575236
• UDI-Public: (01)15099590575236(17)200531(11)180601(10)724813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 33520
• Device Lot Number: 724813
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/28/2019
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2018
• 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