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

Model Number	04V5121
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated alinity c total bilirubin results for a (b)(6) male patient.The following data was provided (customer¿s normal range is 6-12 mg/dl): sample id (b)(6) initial result, on (b)(6) 2022, was 23.3 mg/dl, repeated using a roche assay was 12 mg/dl.The patient was redrawn, after phototherapy, and the result was 24.6 mg/dl, repeated at (b)(6) lab was 16.30, repeated at (b)(6) lab was 16.37 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity c total bilirubin results, when compared to the roche method, included a review of data and information provided by the customer, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for falsely elevated results for the product.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Manufacturing documentation for the likely cause list number were reviewed and did not identify any issues.File sample analysis was not performed as the issue appears to be specific to the documented patient samples.The issue was not reported to have been observed with samples from any other patient.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency with the alinity c total bilirubin reagent, lot number 59369uq03, was identified.

• 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: 14250563
• Report Number: 3002809144-2022-00146
• Device Sequence Number: 14713216
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: 00380740158415
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 05/27/2022

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: 08/31/2022
• Device Model Number: 04V5121
• Device Catalogue Number: 04V51-21
• Device Lot Number: 59369UQ03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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, (B)(4).; ALNTY C PROCESSING MODU, 03R67-01, (B)(4).
• Patient Age: 1 DA
• Patient Sex: Male