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
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/13/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• Manufacturer (Section D): CHASKA DISCRETE MFG IO; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8114858
• Report Number: 2122870-2018-01033
• Device Sequence Number: 295001
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)190131(11)20190131(10)724425
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K001935
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 11/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other