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

Model Number 04T7520

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 282918289
• Report Number: 3002809144-2021-00646
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: 00380740150815
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI01971; ALNTY I PROCESSING MODU, 03R65-01, AI01971