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

Catalog Number	04V51-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely depressed alinity c total bilirubin results for one patient.A new sample was ran and had higher results.The following data was provided: sid (b)(6) processed on(b)(6) 2024 initial result = 1.08 mg/dl sid (b)(6) new sample result = 10.97 mg/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
Complete information for section a1 product identifier sid (b)(6) and sid (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for a falsely depressed total bilirubin result for one patient while using alinity c total bilirubin reagent kit ln 04v51-21, lot 65503uq12 included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending of the complaint issue did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.A new sample was collected from the same patient and tested on the same instrument with the same reagent and gave the expected results.Based on the available information, no systemic issue or deficiency of the alinity c total bilirubin reagent kit ln 04v51-21, lot 65503uq12 was identified.
Event or Problem Description
The customer reported falsely depressed alinity c total bilirubin results for one patient.A new sample was ran and had higher results.The following data was provided: sid (b)(6) processed on (b)(6) 2024 initial result = 1.08 mg/dl.Sid (b)(6) new sample result = 10.97 mg/dl there was no impact to patient management reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19558341
• Report Number: 3002809144-2024-00175
• Device Sequence Number: 4850628
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: (01)00380740158415(17)240531(10)65503UQ12
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/05/2024

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: 05/31/2025
• Device Catalogue Number: 04V51-21
• Device Lot Number: 65503UQ12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown