MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY I INSULIN

Catalog Number	04T75-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: INSULIN
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8358442
• Report Number: 3002809144-2019-00067
• Device Sequence Number: 1098649
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: 00380740150815
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (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): 04/01/2019

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: 05/30/2019
• Device Catalogue Number: 04T75-20
• Device Lot Number: 93511LP16
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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: ALINITY I ANALYZER; ALINITY I ANALYZER; LN 03R65-01 SN (B)(4); LN 03R65-01 SN (B)(4)