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

Catalog Number	08K25-27
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Accuracy testing was completed to evaluate the assay performance using a file kit of reagent lot 00915g000.All replicates met acceptance criteria and the testing passed.A study was reviewed (b)(6).This study looked at the performance characteristics of 6 intact parathyroid hormone assays, including the architect which was the comparison method.For method comparison, serum and edta plasma samples were tested by all methods.Overall the study found good correlation for all methods, but did indicate there was significant bias between methods.The study also concluded that there are many factors that potentially influence variability for pth measurements, including the method used, pth source (synthetic vs endogenous), population evaluated, vitamin d status, preanalytic variables such as sample matrix, and storage time and temperature.The study assessed some of these factors that can produce variability and confirmed that there is variability between pth assays.In conclusion the study indicated that standardization efforts are warranted and assay-specific decision limits are required.A malfunction was identified.Based on the information within the complaint record, the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, a systemic issue and/or product deficiency was not identified.
Event or Problem Description
The customer expressed concern regarding architect intact pth (ipth) results being elevated when compared to another laboratory which recovered normal values for the same patient samples.Architect ipth values of 112.1, 123.4, 117.2, 100.4 and 147.7 pg/ml were generated for samples that tested at 61, 30, 42, 32 and 39 pg/ml respectively using an electrochemiluminescent method at another laboratory.The five patients have normal calcium, creatinine and vitamin d values.No adverse impact to patient management 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: 6564545
• Report Number: 3002809144-2017-00059
• Device Sequence Number: 904968
• Product Code: CEW
• UDI-Device Identifier: 00380740048471
• UDI-Public: 00380740048471
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2017

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 Catalogue Number: 08K25-27
• Device Lot Number: 00915G000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 05/12/2017
• 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 ANALYZER, LIST 01L86-40; SERIAL I1SR55670