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

Catalog Number	08K25-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided no returns were made available from the customer site for this investigation.The investigation of the customer issue included a review of complaint text, a search for similar complaints, accuracy testing, a literature review, and a review of labeling.A lot search for reagent lot 02416a000 did not identify atypical complaint activity.Accuracy testing was performed using in-house file samples of reagent lot 02416a000 and met acceptance criteria.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.The architect intact pth assay package insert contains information to address the current customer issue.Based on the results of this investigation and the information from the customer site no product deficiency was identified.
Event or Problem Description
The customer observed falsely elevated ipth results on the architect i2000sr analyzer.The following data was provided: architect = 95, on another unknown method at the hospital = 67 (42% shift).The patient was scheduled for an unnecessary parathyroidectomy based on the architect results, but the procedure was cancelled upon the repeat result at the hospital.There was no further impact to patient management.

• 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: 6556071
• Report Number: 3002809144-2017-00055
• Device Sequence Number: 324125
• Product Code: CEW
• UDI-Device Identifier: 00380740048471
• UDI-Public: 00380740048471
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/09/2017

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: 05/08/2017
• Device Catalogue Number: 08K25-27
• Device Lot Number: 02416A000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 05/09/2017
• 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 I2000SR ANALYZER; LN 03M74-98 SN (B)(4)