MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I INTACT PTH REAGENT KIT; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Model Number	08P3121
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely increased alinity i intact pth results for several patients.There were complaints about patient results being elevated from several physicians.So, the customer sent some of their samples to another laboratory to compare the results on the other lab¿s alinity analyzer.The following data was provided: the customer¿s result was 55.0, other lab¿s result was 33.1 pg/ml the customer¿s result was 144.3, other lab¿s result was 107.0 pg/ml the customer¿s result was 82.1, other lab¿s result was 61.0 pg/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i intact pth results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review.Trending review determined no related trend for the issue for the product.Testing was completed using retained samples of the complaint lots.Acceptance criteria were met, which indicates acceptable product performance.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i intact pth, lot number 00623l820, 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: ALINITY I INTACT PTH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11748421
• Report Number: 3002809144-2021-00281
• Device Sequence Number: 11851376
• Product Code: CEW
• UDI-Device Identifier: 00380740136215
• UDI-Public: 00380740136215
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/26/2021

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: 12/19/2021
• Device Model Number: 08P3121
• Device Catalogue Number: 08P31-21
• Device Lot Number: 00623L820
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: ALNTY I PROCESSING MODU, 03R65-01, AI04218; ALNTY I PROCESSING MODU, 03R65-01, AI04218; ALNTY I PROCESSING MODU, 03R65-01, AI04219; ALNTY I PROCESSING MODU, 03R65-01, AI04219