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	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed (b)(6) alinity i insulin results on a newborn baby.The initial result on (b)(6) 2021 for sid (b)(4) was (b)(6) uu/ml normal ((b)(6) to (b)(6) uu/ml), the second sample sid (b)(4) had an initial result of (b)(6) uu/ml, repeated (b)(6) / (b)(6) / (b)(6) / (b)(6) / (b)(6) / (b)(6) / (b)(6) / (b)(6) uu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Patient identifier: sid sid (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The ticket search by lot indicates that the reagent lot perform as expected for this product.Return testing was not completed as returns were not available.Trending review did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with lot 97511lp66 and the complaint issue.Accuracy testing was performed to evaluate the performance of reagent lot 97511lp66.An internal alinity i insulin panel was tested with retained kits of the likely cause reagent lot.Acceptance criteria was met, which indicates acceptable product performance.Labeling was reviewed and found to adequately address the issue of falsely elevated results.Based on the investigation, no systemic issue or deficiency of the alinity i insulin reagent lot 97511lp66 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12797438
• Report Number: 3002809144-2021-00646
• Device Sequence Number: 12159797
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: 00380740150815
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 02/08/2022
• Device Model Number: 04T7520
• Device Catalogue Number: 04T75-20
• Device Lot Number: 97511LP66
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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, AI01971; ALNTY I PROCESSING MODU, 03R65-01, AI01971
• Patient Sex: Unknown