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

Catalog Number	04V51-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
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.Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed depressed alinity c total bilirubin results.On (b)(6) 2026, sid (b)(6) (2 day old, male) generated alinity c total bilirubin initial result of 0.4 mg/dl, and the result was released.The result was questioned by the provided.The same sample was repeated on a different alinity processing module 30 minutes later with results of 18.6, 18.6 mg/dl.The sample repeated again on the original alinity processing module of 18.7 mg/dl.A corrected report sent out to provider of 18.6 mg/dl.The customer does not have normal range for <7 days old.No impact to patient management was reported.
Event or Problem Description
The customer observed depressed alinity c total bilirubin results.On (b)(6) 2026, sid (b)(6) (2 day old, male) generated alinity c total bilirubin initial result of 0.4 mg/dl, and the result was released.The result was questioned by the provided.The same sample was repeated on a different alinity processing module 30 minutes later with results of 18.6, 18.6 mg/dl.The sample repeated again on the original alinity processing module of 18.7 mg/dl.A corrected report sent out to provider of 18.6 mg/dl.The customer does not have normal range for <7 days old.No impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and supported the complaint issue.A review of tracking and trending for the alinity c total bilirubin assay did not identify any trends related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 68520uq05.A review of the device history record did not identify any non-conformances, potential non-conformances, or deviations with lot 68520uq05 and the complaint issue.Historical performance of the alinity c total bilirubin reagent lot 68520uq05 was reviewed using field data from customers worldwide.The patient¿s data was analyzed and compared to an established control limit.The patient median result for lot 68520uq05 is within the established control limits; therefore, no unusual reagent lot performance was identified.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the alinity c total bilirubin reagent, lot number 68520uq05.

• 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: 24369495
• Report Number: 3002809144-2026-00044
• Device Sequence Number: 9781775
• Product Code: CIG
• UDI-Device Identifier: 00380740158422
• UDI-Public: (01)00380740158422(17)261031(10)68520UQ05
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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 Catalogue Number: 04V51-31
• Device Lot Number: 68520UQ05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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 Age: 2 DA
• Patient Sex: Male