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

Catalog Number	04V51-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity c total bilirubin results generated on the alinity c processing module for five newborn patients.There was no visible hemolysis for the serum samples.The customer stated the results from other platforms were lower.It the following data was provided: patient 1: alinity c total bilirubin (serum) result = 15.1 mg/dl.Ega (blood gas) capillary result = 12.2 mg/dl.Bilistick result = 12.0 mg/dl.Patient 2: alinity c total bilirubin (serum) result = 17.4 mg/dl.Ega (blood gas) capillary result = 13.8 mg/dl.Bilistick result = n/a.Patient 3: alinity c total bilirubin (serum) result = 15.6 mg/dl.Ega (blood gas) capillary result = 10.0 mg/dl.Bilistick result = 12.7 mg/dl.Patient 4: alinity c total bilirubin (serum) result = 18.1 mg/dl.Ega (blood gas) capillary result = 13.2 mg/dl.Bilistick result = 14.5 mg/dl.Patient 5: alinity c total bilirubin (serum) result = 16.7 mg/dl.Ega (blood gas) capillary result = 12.6 mg/dl.Bilistick result = 12.9 mg/dl.Customer¿s cut off for hospitalization = 14.0 mg/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
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 alinity c total bilirubin results generated on the alinity c processing module for five newborn patients.There was no visible hemolysis for the serum samples.The customer stated the results from other platforms were lower.It the following data was provided: patient 1: alinity c total bilirubin (serum) result = 15.1 mg/dl ega (blood gas) capillary result = 12.2 mg/dl bilistick result = 12.0 mg/dl patient 2: alinity c total bilirubin (serum) result = 17.4 mg/dl ega (blood gas) capillary result = 13.8 mg/dl bilistick result = n/a patient 3: alinity c total bilirubin (serum) result = 15.6 mg/dl ega (blood gas) capillary result = 10.0 mg/dl bilistick result = 12.7 mg/dl patient 4: alinity c total bilirubin (serum) result = 18.1 mg/dl ega (blood gas) capillary result = 13.2 mg/dl bilistick result = 14.5 mg/dl patient 5: alinity c total bilirubin (serum) result = 16.7 mg/dl ega (blood gas) capillary result = 12.6 mg/dl bilistick result = 12.9 mg/dl customer¿s cut off for hospitalization = 14.0 mg/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
Section d4 - primary udi number: this section was corrected from (b)(4).The complaint investigation for discrepant alinity c total bilirubin result 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.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot number 64652uq07 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c total bilirubin assay for lot 64652uq07 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18649195
• Report Number: 3002809144-2024-00029
• Device Sequence Number: 8107560
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: (01)00380740158415(17)241231(10)64652UQ07
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/25/2024

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: 12/31/2024
• Device Catalogue Number: 04V51-21
• Device Lot Number: 64652UQ07
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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