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

Catalog Number	33520
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8524260
• Report Number: 2122870-2019-01070
• Device Sequence Number: 2675899
• Product Code: CGJ
• UDI-Device Identifier: 15099590575236
• UDI-Public: (01)15099590575236(17)200531(11)180601(10)724813
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 33520
• Device Lot Number: 724813
• Distributor Facility Aware Date: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other