MAUDE Adverse Event Report: CHASKA DISCRETE MFG IO ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER; RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Model Number 33560

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

The customer did not provide patient demographics such as age, date of birth, gender, weight, ethnicity, and race.The testosterone reagent was not returned for evaluation.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.Customer technical support completed troubleshooting and hardware verification with the customer via phone.Testosterone precision runs were requested and recovered within precision claim.The cause of this event could not be determined with the available information.

Event Description

The customer reported obtaining non-reproducible estradiol, tsh, free t3, and testosterone patient results involving the laboratory's access 2 immunoassay analyzer (serial number (b)(4)).There was a change to treatment for one patient based on a testosterone result.The patient had a change in injection amount.There was no reported injury or illness to the patient in this event.Quality control (qc) recovered outside customer¿s established ranges for multiple assays.The customer recalibrated and/or used fresh qc and recovered within range.No issues with sample integrity were reported by the customer for this initial sample.

• Brand Name: ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER
• Type of Device: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• 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 ; brea, CA 92821-8000
• MDR Report Key: 8114858
• MDR Text Key: 128732256
• Report Number: 2122870-2018-01033
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)190131(11)20190131(10)724425
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001935
• 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: 11/29/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 33560
• Device Catalogue Number: 33560
• Device Lot Number: 724425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other