MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT IPTH; INTACT PARATHYROID HORMONE

Catalog Number	08K25-27
Medical Device Problem Codes	Incorrect Or Inadequate Test Results (2456); High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the customer issue included complaint text review, a search for similar complaints, device history review, instrument log review, labeling review, and field data review.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Log review did not identify any issues that contributed to the customer issue.Labeling was reviewed and found to be adequate.Abbott link world wide data was used to evaluate product historical performance field data.Patient data from (b)(6) 2017 to (b)(6) 2018 was analyzed and compared to an established control limit.The evaluation indicated that the complaint lot patient median result was within the established control limits and performance was comparable to other lots in the field.No unusual reagent lot performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.
Event or Problem Description
The customer observed multiple falsely elevated intact parathyroid hormone (pth) results while using architect intact pth reagents.The patients are dialysis patients and are tested monthly.The following data was provided.(b)(6) (tested (b)(6) 2018) 496 pg/ml.Previous result ((b)(6) tested (b)(6) 2018) was lower, 346 pg/ml.The patient was given medication, hectorol (2 mcg iv) due to the falsely elevated may result.(b)(6) (tested (b)(6) 2018) 486 pg/ml.Previous result ((b)(6) tested (b)(6) 2018) was lower, 182 pg/ml.Hectorol iv medication for the patient was increased from 5 mcg to 6 mcg due to the falsely elevated may result.No adverse impact to patients was reported.

• Brand Name: ARCHITECT IPTH
• Common Device Name: INTACT PARATHYROID HORMONE
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7574460
• Report Number: 3002809144-2018-00059
• Device Sequence Number: 2144019
• Product Code: CEW
• UDI-Device Identifier: 00380740048471
• UDI-Public: 00380740048471
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K063232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2018

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: 02/03/2019
• Device Catalogue Number: 08K25-27
• Device Lot Number: 03317K000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1