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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's date of birth and weight were not supplied.There is no evidence that the access intact pth reagent was returned for evaluation.The patient's sample was sent to the beckman coulter complaint handling unit for testing.The patient sample was analyzed on the access 2 immunoassay system serial number (b)(4), and recovered with elevated access intact pth results.These results confirmed the results obtained by the customer.Dilution testing was performed.The dilution test results were non-linear, indicating the possible presence of a patient-source interferent.Interference testing using heterophile (hbr-1) and alkaline phosphatase (alp) interference blockers was performed.The addition of alp blocker significantly decreased result recovery; a patient-source interferent was confirmed.The cause of this event is the presence of alkaline phosphatase (alp) interferents in the patient sample.The access intact pth assay instructions for use (ifu), (b)(4), does not include alp as a possible patient-source interferent.
Event or Problem Description
The customer reported that one patient's sample recovered with reproducibly elevated intact parathyroid hormone (access intact pth) results involving the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)).On (b)(6) 2016 the initial access intact pth result recovered at 3044.7 pg/ml, above the assay's normal reference range of 12 - 88 pg/ml.Dilution testing of the sample was performed on the same unicel dxi 800 access immunoassay system and recovered non-linearly, indicating a patient source interferent.On (b)(6) 2016, the same patient's sample was retested and recovered with a result of 3055.1 pg/ml, above the normal reference range.Dilution testing was repeated and recovered with lower, non-linear results.The initial access intact pth result was released from the laboratory.There was no report of change to patient treatment in conjunction with this event.The customer reported that quality control was within specifications before and after the event.No hardware errors, flags or other assay issues were reported in conjunction with this event.Information on calibration and system check was not supplied information on the patient sample collection and processing was not provided by the customer.

• 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: 6305911
• Report Number: 2122870-2017-00007
• Device Sequence Number: 10961882
• Product Code: CEW
• UDI-Device Identifier: 15099590201937
• UDI-Public: (01)15099590201937(17)170430(11)160427(10)623722
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: A16972
• Device Lot Number: 623722
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR