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	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
A literature article by p.Dufour, e.Brevers, n.Paquot, c.Le goff, e.Cavalier, and a.Landang, ¿laboratory exploration of a very high level of insulin measured in an long-standing type 1 diabetic patient¿, clinical chemistry and laboratory medicine 61.3: ea15-ea16.Walter de gruyter gmbh.(jan 2023), documented falsely elevated alinity i insulin results when compared to another method.The study noted falsely elevated alinity i insulin results for a 67 year old female patient who was diagnosed with type 1 diabetes 50 years ago.During routine testing the insulin results were 11850 pmol/l and glucose results were 159 mg/dl.The patient did not present any signs of hypoglycemia and therapeutic insulin overdose was excluded.The insulin concentrations were also measured with siemens atellica (1590 pmol/l) and roche cobas (6.74 pmol/l).The sample was treated with veraprep which excluded heterophilic antibody interference.Macroinsulin was suspected and the sample was treated with polyethylene glycol precipitation (peg) and a recovery of 8% was observed.The presence of anti-insulin antibodies was also measured with another manufacturer generating results of 16.09 u/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i insulin results included a review of the article, 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 44511lp97.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 unknown was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16511721
• Report Number: 3002809144-2023-00111
• Device Sequence Number: 6758297
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: 00380740150815
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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 Model Number: 04T7520
• Device Catalogue Number: 04T75-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown