MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS INTACT PTH; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Model Number	A16972
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The customer did not supply patient demographics such as sex, weight, ethnicity or race.There is sufficient evidence to suggest an imprecision malfunction occurred as 3 or more replicates of the same sample on the same device recovered outside the expected assay precision.Available system performance indicators of passing system check and quality control recovery did not demonstrate an issue with the system.No other patient results were called into question.No error messages or issues with other assays were reported in connection with this event.There were no reports of hardware interventions performed or hardware parts replaced.In conclusion, a definitive cause of the imprecision malfunction cannot be determined with the available information.The root cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2020 the customer reported obtaining one non-reproducible false elevated parathyroid hormone pth(access intact pth, part number a16972, lot number 971134) patient result involving the laboratory's unicel dxi 800 access immunoassay analyzer (part number 973100, serial number (b)(4)).The initial result of 623.65 pg/ml (12:24) was questioned and repeated at 24.46 pg/ml (14:57).The sample was repeated twice again and similar lower results were obtained: 25.13 pg/ml and 22.95 pg/ml (both at 17:25).The customer normal reference range is 12 - 88 pg/ml.System check and calibration have been passing and qc was within the laboratory¿s established ranges.No error messages or issues with other assays were reported in connection with this event.There were no reports of hardware interventions performed or hardware parts replaced.Sample tube collection type was not provided.Sample processing information such as centrifugation time, speed and temperature were not provided.There was no report of sample integrity issues.No further sample information was provided.

• Brand Name: ACCESS INTACT PTH
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• MDR Report Key: 11108557
• Report Number: 9680746-2021-00054
• Device Sequence Number: 19731906
• Product Code: CEW
• UDI-Device Identifier: 15099590201937
• UDI-Public: (01)15099590201937(17)210131(11)200201(10)971134
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/04/2021

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: 01/31/2021
• Device Model Number: A16972
• Device Catalogue Number: A16972
• Device Lot Number: 971134
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR