MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I INSULIN

Model Number 04T7520

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information: all available patient information was included.Additional patient details are not available.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer obtained a falsely elevated alinity i insulin result.Sample id (b)(6) generated a flagged result of >3000 uu/ml, diluted 1:100 8547.5 uu/ml and diluted 1:200 9093.2 uu/ml.The sample was tested on roche generating 4 uu/ml.No impact to patient management was reported.

Manufacturer Narrative

The reagent lot was provided by the customer and lot number was change from unknown to 03511lp27.Investigation of the customer's issue included a review of the complaint text, a search for similar complaints, retained kit testing of an alternate lot and review of manufacturing and labeling documentation.Review of complaint trending reports did not identify any trends for the alinity i insulin assay.Review of complaint activity for reagent lot 03511lp27 did not identify an increase in complaint activity.Return testing was not completed as returns were not available.Since reagent lot 03511lp27 expired on december 7, 2019, a representative reagent lot (05511lp30) was used to assess the performance of the assay.An internal insulin panel, which has known concentrations, was tested with the reagent lot.All specifications were met indicating the assay is performing acceptably.Manufacturing documentation for the reagent lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no systemic issue or deficiency of the alinity i insulin assay was identified.

• Brand Name: ALINITY I INSULIN
• Type of Device: INSULIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9554488
• MDR Text Key: 188321942
• Report Number: 3002809144-2020-00013
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: 00380740150815
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2019
• Device Model Number: 04T7520
• Device Catalogue Number: 04T75-20
• Device Lot Number: 03511LP27
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE,; ALINITY I PROCESSING MODULE,; LIST 03R65-01, SERIAL (B)(6); LIST 03R65-01, SERIAL (B)(6)