MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C TOTAL BILIRUBIN REAGENT KIT; DIAZO COLORIMETRY, BILIRUBIN

Model Number	04V5131
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely depressed total bilirubin result generated on an alinity c processing module for a (b)(6) baby boy.Sid (b)(6).There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.File sample analysis was not performed as the sample was repeated and acceptable result was produced.Ticket and trending review did not identify trends for the complaint issue.Device history record review did not identify any non-conformances or deviations with the likely cause list number and complaint issue.Labeling was reviewed and found to sufficiently address the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the alinity c total bilirubin reagent lot 59708uq04 was identified.Additional information in section d10 concomitant product.

• Brand Name: ALINITY C TOTAL BILIRUBIN REAGENT KIT
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13967639
• Report Number: 3002809144-2022-00112
• Device Sequence Number: 20025659
• Product Code: CIG
• UDI-Device Identifier: 00380740158422
• UDI-Public: 00380740158422
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 09/30/2022
• Device Model Number: 04V5131
• Device Catalogue Number: 04V51-31
• Device Lot Number: 59708UQ04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ALNTY C PROCESSING MODU, 03R67-01, AC03815.
• Patient Age: 4 DA
• Patient Sex: Male