MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I INSULIN REAGENT KIT; RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Model Number	04T7520
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Was this device serviced by a third party? no.Patient identifier: multiple = sid (b)(6), sid (b)(6), sid (b)(6), sid (b)(6).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 physician questioned falsely elevated alinity i insulin results on a female patient.The results provided were: (b)(6).No adverse 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, and device history records.Return testing was not completed as returns were not available.A ticket search for lot 23511lp58 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 23511lp58 and the complaint issue.Labeling was reviewed and found to adequately address the issue of falsely elevated results.Testing was completed using retained samples of the complaint lot.Acceptance criteria were met, which indicates acceptable product performance.Based on the investigation, no systemic issue or deficiency of the alinity i insulin for lot 23511lp58 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 INSULIN REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11649152
• Report Number: 3002809144-2021-00247
• Device Sequence Number: 19791353
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: 00380740150815
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 09/30/2021
• Device Model Number: 04T7520
• Device Catalogue Number: 04T75-20
• Device Lot Number: 23511LP58
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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, AI04002; ALNTY I PROCESSING MODU, 03R65-01, AI04002