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

Model Number	8K25-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, did not contain enough spaces, the entire sid (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account generated false elevated architect intact pth of 96.9 pg/ml (reference range 8.5 to 72.5 pg/ml) on a patient sid (b)(6) who tested roche method of 61.3 pg/ml (reference range 15 to 65 pg/ml) and beckman method of 72 pg/ml (reference range 12 to 88 pg/ml).No impact to patient management was reported.No specific patient information was provided.
Additional Manufacturer Narrative
The complaint evaluation included review of complaint text, a search for similar complaints, trending data, labeling, device history records, historical performance of reagent lot 05119e000 and file lot with sample return analysis.No instrument logfile review was performed as the sample id was not found in logfiles.A ticket search for lot 05119e000 did not identify an increase in complaint activity related to falsely elevated results.A review of ticket trending data for the architect intact pth was performed.No adverse trends were identified.Labeling was reviewed and found to adequately address the issue of falsely elevated results.Device history record review was performed on lot 05119e000, which did not show any potential non-conformances or deviations.The historical performance of reagent lot 05119e000 was evaluated using world wide data.Patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 05119e000 is inside the established control limits, which indicates acceptable product performance.Additionally, analytical specificity testing was performed for the customer-returned patient samples and results showed evidence of a potential interferent.The customer-returned patient sample was treated with a heterophilic blocking tube (hbt).The hbt produced results different to the neat sample which indicates the interference was possibly due to heterophilic antibodies.No product deficiency of the architect intact pth reagent lot 05119e000 was identified.

• Brand Name: ARCHITECT IPTH
• Common Device Name: INTACT PARATHYROID HORMONE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10040808
• Report Number: 3002809144-2020-00377
• Device Sequence Number: 2812736
• Product Code: CEW
• UDI-Device Identifier: 00380740048471
• UDI-Public: 00380740048471
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/03/2020

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: 11/24/2020
• Device Model Number: 8K25-27
• Device Catalogue Number: 08K25-27
• Device Lot Number: 05119E000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 08/03/2020
• 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 LIST 03M74-02; ARCHITECT I2000SR LIST 03M74-02; SERIAL (B)(6); SERIAL (B)(6)