MAUDE Adverse Event Report: CHASKA DISCRETE MFG IO ACCESS TESTOSTERONE

Model Number 33560

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site.No hardware errors, flags or other assay issues were reported in conjunction with this incident.There is no evidence that the testosterone reagent was returned for evaluation.A dilution study was performed by the customer on sample six (6) from (b)(6) 2018, as recommended in the information for use (ifu).Per the testosterone instructions for use (ifu), part number a33261, it states ¿using weighted cubic regression, the access testosterone assay was linear, with a maximum deviation from linearity of 9.1% for samples > 1.4 ng/ml.Samples = 1.4 ng/ml demonstrated a maximum deviation from linearity of 0.15 ng/ml.¿ heterophile interference is the cause of the elevated testosterone results obtained by the customer as the dilution test carried out by the customer generated non-linear results.The exact nature of interference cannot be determined without further testing.Per the testosterone ifu ¿for assays employing antibodies, the possibility exists for interference by heterophile antibodies in the patient sample.Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e.G.Hama, that interfere with immunoassays.Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in patient samples.Such interfering antibodies may cause erroneous results.Carefully evaluate the results of patients suspected of having these antibodies.¿ beckman coulter has requested a patient sample for interference testing.The customer will sent the sample for investigation if the patient agrees to come back for a re-draw.(b)(4).

Event Description

The customer reported obtaining reproducible high testosterone results for one (1) patient involving the laboratory's unicel dxi 800 immunoassay systems (serial number (b)(4)).Four (4) different samples from this same patient gave high testosterone results between (b)(6) 2017 and (b)(6) 2018.The patient underwent surgical removal of the ovaries in (b)(6) 2018 because of the elevated testosterone results as well as the patient clinical picture.The patient presented hirsutism on the face, bigger than expected ovaries and hair loss.The patient is a (b)(6)-year-old postmenopausal female.No other change to treatment has been reported by the customer.Results post-surgery were discordant to the patient clinical file.Testing on the siemens advia centaur recovered within the expected range.No hardware errors, flags or other assay issues were reported in conjunction with this incident.

• Brand Name: ACCESS TESTOSTERONE
• Type of Device: ACCESS TESTOSTERONE
• Manufacturer (Section D): CHASKA DISCRETE MFG IO; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): CHASKA DISCRETE MFG IO; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: david davis ; 250 south kraemer boulevard; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8151351
• MDR Text Key: 129932758
• Report Number: 2122870-2018-01034
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)181130(11)20181130(10)724408
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K001935
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 33560
• Device Catalogue Number: 33560
• Device Lot Number: 724408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR