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

Catalog Number	04T75-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity i insulin results for a patient with 2 different sample draws.The following data was provided for (b)(6), a 66-year-old male, diabetic/hypoglycemia patient not using insulin analogs.(b)(6) 2023; insulin results were 896 u/ml and clinical history results were on (b)(6) 2023; 593 u/ml, (b)(6) 2023; 1174 u/ml, (b)(6) 2023; 720 u/ml another sample was re-drowned and tested on tosoh aia and the insulin results were 200-300 u/ml.Alinity results with 1:1 dilution; > 300 u/ml, 1:2 dilution >600 u/ml.And manual 896.49 u/ml.The customer uses an insulin reference range of 5-10u/ml.There was no impact to patient management was reported.
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 alinity i insulin results for a patient with 2 different sample draws.The following data was provided for sid (b)(6), a 66-year-old male, diabetic/hypoglycemia patient not using insulin analogs.02aug2023; insulin results were 896 u/ml and clinical history results were on april 19th; 593 u/ml, may 24th; 1174 /ml, june 21st; 720 u/ml.Another sample was re-drowned and tested on tosoh aia and the insulin results were 200-300 u/ml.Alinity results with 1:1 dilution; > 300 u/ml, 1:2 dilution >600 u/ml.And manual 896.49 u/ml.The customer uses an insulin reference range of 5-10 u/ml.There was no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i insulin results was completed to include search for similar complaints, trending data review, device history record review, labeling review, and in-house testing.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review on list 4t75 did not show any nonconformances, potential non-conformances, or deviations.In-house accuracy testing was completed with representative lot number 48511lp06.Testing met validity and acceptance criteria which indicates acceptable product performance.Labeling was reviewed and found to adequately address the issue under review.Based on our investigation, no systemic issue or deficiency with the alinity i insulin reagent for lot 48511lp06 was identified.Section g1- all manufacturers, contact information and phone numbers were updated.

• 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17746781
• Report Number: 3002809144-2023-00393
• Device Sequence Number: 4236166
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: 00380740150815
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/20/2023

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: 10/19/2023
• Device Catalogue Number: 04T75-20
• Device Lot Number: 48511LP06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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, AI01658; ALNTY I PROCESSING MODU, 03R65-01, AI01658
• Patient Age: 66 YR
• Patient Sex: Male