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

Model Number	8K25-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported that a provider questioned falsely elevated architect intact pth results (confirmed by repeat and then by recollection) that conflicted with a high normal value obtained by the patient at labcorp at about the same time.The initial architect intact pth result from (b)(6) 2021 was sid (b)(4) 106.1 pg/ml (current reference range: 15.0 pg/ml to 73.5 pg/ml); quest: 54 pg/ml (quest reference range: 14 pg/ml to 64 pg/ml); labcorp: 61 pg/ml (labcorp reference range: 15 pg/ml to 65 pg/ml).No impact to patient management was reported.
Additional Manufacturer Narrative
The investigation included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records and historical performance of reagent lot 02619l000.A ticket search for lot 02619l000 did not identify an increase in complaint activity related to falsely elevated results.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with lot 02619l000 and the complaint issue.Labeling was reviewed and found to adequately address the issue of falsely elevated results.Historical performance of reagent lot 02619l000 was evaluated using world-wide field data.Patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 02619l000 was within the established control limits; therefore, no unusual reagent lot performance was identified for lot 02619l000.Based on the investigation no systemic issue or deficiency of the architect intact pth for lot number 02619l000 was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• 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: 11726826
• Report Number: 3002809144-2021-00267
• Device Sequence Number: 3019001
• Product Code: CEW
• UDI-Device Identifier: 00380740048471
• UDI-Public: 00380740048471
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/10/2021

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: 06/12/2021
• Device Model Number: 8K25-27
• Device Catalogue Number: 08K25-27
• Device Lot Number: 02619L000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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, I1SR52287; ARC I1000SR MOD, 01L86-01, I1SR52287