MAUDE Adverse Event Report: BECKMAN COULTER ACCESS INTACT PTH REAGENT; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Catalog Number	A16972
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access intact pth reagent was not returned for evaluation.During guided troubleshooting with beckman coulter (bec) customer technical support (cts) the customer completed the carryover test and precision run which were within specifications.A beckman coulter field service engineer was dispatched to evaluate the instrument's performance, but this service was canceled by the customer as they were satisfied with the instrument performance and the troubleshooting performed by the beckman coulter customer technical support.In conclusion.An assignable cause for this event could not be determined with the information provided.There is no evidence to reasonably suggest a system malfunction; system parameters (system checks, precision studies, calibrations, quality control) met assay and instrument specifications.
Event or Problem Description
The customer reported obtaining non-reproducible elevated intact parathyroid hormone (access intact pth) results for two patients involving the laboratory's access 2 immunoassay system (serial (b)(4)).The customer reanalyzed the patients' samples on the same access 2 immunoassay system and an alternate access 2 immunoassay system (serial (b)(4)) and obtained lower results.The initial results were released from the laboratory.There was a change to patient care attributable to this event for one patient as a repeat biopsy was ordered by the physician due to the elevated access intact pth result.There was no report of injury or change in patient treatment associated with the second patient.The customer could not identify which of the two patients had a change in treatment.Quality control (qc), calibration and system check were performing within assay and instrument specifications at the time of the event.There were no hardware errors or other assay issues reported in conjunction with this event.The patient samples were collected in ethylenediaminetetraacetic acid (edta) plasma tubes and centrifuged at 3000 revolutions per minute (rpm) for seven minutes at 5-6 degrees celsius.No issues with sample integrity were reported.

• Brand Name: ACCESS INTACT PTH REAGENT
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 7313134
• Report Number: 2122870-2018-00017
• Device Sequence Number: 1476114
• Product Code: CEW
• UDI-Device Identifier: 15099590201937
• UDI-Public: (01)15099590201937(17)180430(11)180508(10)723684
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K061190
• 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): 02/13/2018

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: 04/30/2018
• Device Catalogue Number: A16972
• Device Lot Number: 723684
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/05/2018
• 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