MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I INSULIN

Model Number	04T7520
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: INSULIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9554488
• Report Number: 3002809144-2020-00013
• Device Sequence Number: 19683727
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: 00380740150815
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 01/30/2020

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: 12/07/2019
• Device Model Number: 04T7520
• Device Catalogue Number: 04T75-20
• Device Lot Number: 03511LP27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/30/2020
• 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 PROCESSING MODULE,; ALINITY I PROCESSING MODULE,; LIST 03R65-01, SERIAL (B)(6); LIST 03R65-01, SERIAL (B)(6)