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

Catalog Number	08K25-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when it is complete.Section a: patient information- no specific patient information was provided.
Event or Problem Description
The customer reported falsely elevated architect intact pth results for multiple patient samples when compared to an alternate method.Patient 1: 131 pg/ml on architect and 39 pg/ml on alternate method.Patient 2: 146 pg/ml on architect and 58 pg/ml on alternate method.Patient 3: 287 pg/ml on architect and 113 pg/ml on alternate method.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity determined that there was normal complaint activity for the likely cause lot 01517k000, however the trend review did identify increased activity for falsely elevated results.Since no return samples were available, sample specific testing could not be performed.Using worldwide field data the performance of reagent lot 01517k000 was evaluated.The patient median result of the complaint lot was within the established control limits of the architect intact pth assay.A study was reviewed "performance characteristics of six intact parathyroid hormone assays "; sonia l.La'ulu, and william l.Roberts, md, phd.Am j clin pathol 2010;134:930-938, 2010.This study looked at the performance characteristics of six different intact parathyroid hormone assays, including the architect ipth assay, which was the comparison method.Overall, the study found good correlation for all methods, but did indicate there was significant bias between methods.The study concluded that there are many factors that potentially influence variability for pth measurements and that standardization efforts are warranted and assay-specific decision limits are required.Manufacturing documentation for the architect intact pth assay was review and did not identify any issues.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect intact pth assay was identified.

• 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: 8059959
• Report Number: 3002809144-2018-00506
• Device Sequence Number: 1279922
• Product Code: CEW
• UDI-Device Identifier: 00380740048471
• UDI-Public: 00380740048471
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: 05/17/2019
• Device Catalogue Number: 08K25-25
• Device Lot Number: 01517K000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I1000SR, LN 01L8-97,; ARCHITECT I1000SR, LN 01L8-97,; SN (B)(4); SN (B)(4)