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
Regarding date: on (b)(6) 2018; after further evaluation, the suspect medical device in question was changed from the architect i2000sr analyzer, list number (b)(4), to the architect ipth assay, list number (b)(4).This changes the manufacturing location.The event was initially documented under mdr 1628664-2018-00221.All further information will be documented under this mdr number, 3002809144-2018-00072.Investigation of the customer issue included a review of the complaint text, a search for similar complaints, field data review, a design history record (dhr) review, a literature review, and a review of labeling.An analysis utilizing customer field data was used to assess the specificity of the assay.Instrument data analytics (ida) reports for the architect ipth assay were reviewed to determine if the median patient values have shifted over time.The analysis concluded that all reagent lots read patient results consistently therefore determined the reagent is performing acceptably.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.A study was reviewed titled: "performance characteristics of six intact parathyroid hormone assays".The review indicated that while the architect ipth assay showed a positive bias, the correlation between all six of the assays was good.Labeling was reviewed and found to be adequate.Based on the results of this investigation no product deficiency was identified for the architect ipth assay, ln (b)(4), lot number 03317k000.
Event or Problem Description
The customer observed falsely elevated parathyroid hormone(ipth) results while using the architect ipth assay on the architect i2000sr analyzer.The customer indicated that the physician questioned the increase in result.The customer indicated they have a patient who generated a result of 300 a few months ago (no specific date provided or unit of measure) using the roche method.A result of 600 was generated recently using the architect assay.No other information was provided.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: 7635584
• Report Number: 3002809144-2018-00072
• Device Sequence Number: 11059679
• Product Code: CEW
• UDI-Device Identifier: 00380740048471
• UDI-Public: 00380740048471
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/25/2018

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1