MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT IPTH REAGENT KIT; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Model Number	08K2529
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated architect intact pth result on one patient.The results provided were: on (b)(6) 2021 sid (b)(6) initial=173 pg/ml /physician questioned the initial result repeated at labcorp=54 pg/ml.Laboratory reference range for ipth=15 to 68 pg/ml.The customer performed comparison study with quest for troubleshooting purpose.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and historical performance of architect intact pth reagent lot 07620i000.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Historical performance of reagent lot 07620i000 was evaluated using worldwide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 07620i000 is within the established control limits.Therefore, no unusual reagent lot performance was identified.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect intact pth, reagent lot 07620i000.

• Brand Name: ARCHITECT IPTH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12338892
• Report Number: 3002809144-2021-00493
• Device Sequence Number: 5087620
• Product Code: CEW
• UDI-Device Identifier: 00380740156244
• UDI-Public: 00380740156244
• 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
• Serviced by Third Party (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): 08/30/2021

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: 04/23/2022
• Device Model Number: 08K2529
• Device Catalogue Number: 08K25-29
• Device Lot Number: 07620I000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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: ARC I1000SR MOD, 01L86-01, I1SR60776; ARC I1000SR MOD, 01L86-01, I1SR60776