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	11/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity i insulin results for one 88-year-old female patient.The sample was repeated with lower results.The following data was provided: sample id : (b)(6) initial result = 134.6 uu/ml.1st repeat result same instrument = 84.3 uu/ml.2nd repeat result same instrument = 82.7 uu/ml.Repeat from another sample same patient = 66.3 uu/ml.New fasting sample = 32.7 and 33.8.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier is (b)(6).
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i insulin 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, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search determined that there is as expected complaint activity for the likely cause lot.Device history review did not identify any related non-conformances or deviations for the complaint lot.A review of tracking and trending did not identify any trends for the issue for the product.The overall performance of the alinity i insulin reagent in the field was reviewed using data gathered from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 66511lp51 was within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 66511lp51.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 66511lp51 was identified.
Event or Problem Description
The customer observed falsely elevated alinity i insulin results for one 88-year-old female patient.The sample was repeated with lower results.The following data was provided: sample id: (b)(6), initial result = 134.6 uu/ml, 1st repeat result same instrument = 84.3 uu/ml, 2nd repeat result same instrument = 82.7 uu/ml, repeat from another sample same patient = 66.3 uu/ml.New fasting sample = 32.7 and 33.8.No impact to patient management was reported.

• 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: 21002230
• Report Number: 3002809144-2024-00363
• Device Sequence Number: 9858523
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: (01)00380740150815(17)250418(10)66511LP51
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/23/2025

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: 04/18/2025
• Device Catalogue Number: 04T75-20
• Device Lot Number: 66511LP51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 88 YR
• Patient Sex: Female