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

Catalog Number	08K41-28
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated architect insulin results which questioned by the physician for a male patient from different draws.The physician stated the patient taking treatment and insulin results should be within reference range.The following data was provided: on (b)(6) 2023 sid (b)(6) 300 u/ml /redrawn and repeated sid (b)(6) 300 u/ml /redrawn and repeated on (b)(6) 2023 sid (b)(6) 300u/ml.Laboratory reference range for insulin=2 to 20 u/ml no impact to patient management was reported.
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6),(b)(6) and (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint evaluation 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 accuracy testing of architect insulin reagent lot number 56221lp24.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.The ticket search determined that there is as expected complaint activity for the likely cause lot 56221lp24.The accuracy testing was performed for reagent lot 56221lp24 using an internal insulin panel which was tested with a retained kit of the likely cause reagent lot.Acceptance criteria were met, which indicates acceptable product performance.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect insulin reagent lot number 56221lp24.
Event or Problem Description
The customer reported falsely elevated architect insulin results which questioned by the physician for a male patient from different draws.The physician stated the patient taking treatment and insulin results should be within reference range.The following data was provided: on 16nov2023 sid (b)(6) = > 300 u/ml /redrawn and repeated sid 231106595302= > 300 u/ml /redrawn and repeated on 17nov2023 sid (b)(6) => 300 u/ml.Laboratory reference range for insulin=2 to 20 u/ml no impact to patient management was reported.

• Brand Name: ARCHITECT 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: 18427066
• Report Number: 3002809144-2024-00001
• Device Sequence Number: 12687159
• Product Code: CFP
• UDI-Device Identifier: 00380740169824
• UDI-Public: 00380740169824
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/08/2024

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: 06/11/2024
• Device Catalogue Number: 08K41-28
• Device Lot Number: 56221LP24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2SR REFURB-SEKAT, 03M74-97, ISR51690; ARC I2SR REFURB-SEKAT, 03M74-97, ISR51690
• Patient Sex: Male