MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY I INSULIN

Catalog Number 04T75-20

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

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 observed falsely elevated insulin results on the alinity analyzer.The following data was provided: sid (b)(6): initial 2.7, repeats >300 >600, >3,300 compared to another method as 20-30 uu/ml.A new sample was drawn and results in 18.9, 15.8 (matching the other method).There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ALINITY I INSULIN
• Type of Device: INSULIN
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8358442
• MDR Text Key: 137128179
• Report Number: 3002809144-2019-00067
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: 04T75-20
• Device Lot Number: 93511LP16
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I ANALYZER; ALINITY I ANALYZER; LN 03R65-01 SN (B)(4); LN 03R65-01 SN (B)(4)