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

Catalog Number	04V51-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated total bilirubin results generated on the alinity c processing module on multiple patients.The following results were provided: sid date time initial / repeat (another alinity) (b)(6), on (b)(6) 2024, 20:24 16.0 mg/dl; retest 1.2 mg/dl, (b)((6), on (b)(6) 2024, 20:12 3.9 mg/dl; retest 0.3 mg/dl, (b)(6), on (b)(6) 2024, 20:01 3.9 mg/dl; retest 0.3 mg/dl, (b)(6), on (b)(6) 2024, 20:00 4.4 mg/dl; retest 0.5 mg/dl, (b)(6), on (b)(6) 2024, 19:59 7.1 mg/dl; retest 0.6 mg/dl, (b)(6), on (b)(6) 2024, 19:45 15.0 mg/dl; retest 2.1 mg/dl, (b)(6), on (b)(6) 2024, 19:43 7.2 mg/dl; retest 0.9 mg/dl, (b)(6), on (b)(6) 2024, 19:35 7.5 mg/dl; retest 0.9 mg/dl, (b)(6), on (b)(6) 2024, 19:25 14.4 mg/dl; retest 1.2 mg/dl, (b)(6), on (b)(6) 2024, 19:24 4.9 mg/dl; retest 0.4 mg/dl, (b)(6), on (b)(6) 2024, 18:59 5.6 mg/dl; retest 0.3 mg/dl, (b)(6), on (b)(6) 2024, 18:54 5.8 mg/dl; retest 0.7 mg/dl, (b)(6), on (b)(6) 2024, 18:43 6.4 mg/dl; retest 0.6 mg/dl, (b)(6), on (b)(6) 2024, 17:42 6.2 mg/dl; retest 0.6 mg/dl, (b)(6), on (b)(6) 2024, 17:41 3.9 mg/dl; retest 0.4 mg/dl, (b)(6), on (b)(6) 2024, 17:29 5.8 mg/dl; retest 0.5 mg/dl, (b)(6), on (b)(6) 2024, 17:22 >25.0 mg/dl; retest 6.7 mg/dl, (b)(6), on (b)(6) 2024, 17:19 4.6 mg/dl; retest 0.6 mg/dl, (b)(6), on (b)(6) 2024, 17:14 8.0 mg/dl; retest 0.8 mg/dl, (b)(6), on (b)(6) 2024, 17:13 5.2 mg/dl; retest 0.4 mg/dl, (b)(6), on (b)(6) 2024, 17:11 4.5 mg/dl; retest 0.4 mg/dl, (b)(6), on (b)(6) 2024, 17:07 5.3 mg/dl; retest 0.5 mg/dl, (b)(6), on (b)(6) 2024, 16:39 4.9 mg/dl; retest 0.3 mg/dl, (b)(6), on (b)(6) 2024, 16:39 3.7 mg/dl; retest 0.3 mg/dl, reference range: 18 yr - 150 (0 - 1.2 mg/dl).No impact to patient management was reported.
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.Section a1 patient identifier sids: (b)(6).
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause alinity c total bilirubin reagent lot 66829uq08 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances or deviations.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency for the alinity c total bilirubin was identified.
Event or Problem Description
The customer reported falsely elevated total bilirubin results generated on the alinity c processing module on multiple patients.The following results were provided: sid date time initial / repeat (another alinity) (b)(6), (b)(6)2024 20:24 16.0 mg/dl; retest 1.2 mg/dl, (b)(6), (b)(6) 2024 20:12 3.9 mg/dl; retest 0.3 mg/dl, (b)(6), (b)(6)2024 20:01 3.9 mg/dl; retest 0.3 mg/dl, (b)(6), (b)(6) 2024 20:00 4.4 mg/dl; retest 0.5 mg/dl, (b)(6), (b)(6) 2024 19:59 7.1 mg/dl; retest 0.6 mg/dl, (b)(6), (b)(6) 2024 19:45 15.0 mg/dl; retest 2.1 mg/dl, (b)(6), (b)(6) 2024 19:43 7.2 mg/dl; retest 0.9 mg/dl, (b)(6), (b)(6) 2024 19:35 7.5 mg/dl; retest 0.9 mg/dl, (b)(6), (b)(6) 2024 19:25 14.4 mg/dl; retest 1.2 mg/dl, (b)(6), (b)(6) 2024 19:24 4.9 mg/dl; retest 0.4 mg/dl, (b)(6), (b)(6) 2024 18:59 5.6 mg/dl; retest 0.3 mg/dl, (b)(6), (b)(6) 2024 18:54 5.8 mg/dl; retest 0.7 mg/dl, (b)6), (b)(6) 2024 18:43 6.4 mg/dl; retest 0.6 mg/dl, (b)(6), (b)(6) 2024 17:42 6.2 mg/dl; retest 0.6 mg/dl, (b)(6), (b)(6) 2024 17:41 3.9 mg/dl; retest 0.4 mg/dl, (b)(6), (b)(6) 2024 17:29 5.8 mg/dl; retest 0.5 mg/dl, (b)(6), (b)(6) 2024 17:22 >25.0 mg/dl; retest 6.7 mg/dl, (b)(6), (b)(6) 2024 17:19 4.6 mg/dl; retest 0.6 mg/dl, (b)(6), (b)(6) 2024 17:14 8.0 mg/dl; retest 0.8 mg/dl, (b)(6), (b)(6)2024 17:13 5.2 mg/dl; retest 0.4 mg/dl, (b)(6), (b)(6)2024 17:11 4.5 mg/dl; retest 0.4 mg/dl, (b)(6), (b)(6)2024 17:07 5.3 mg/dl; retest 0.5 mg/dl, (b)(6), (b)(6)2024 16:39 4.9 mg/dl; retest 0.3 mg/dl (b)(6), (b)(6)2024 16:39 3.7 mg/dl; retest 0.3 mg/dl, reference range: 18 yr - 150 (0 - 1.2 mg/dl) , no impact to patient management was 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: 21166700
• Report Number: 3002809144-2025-00009
• Device Sequence Number: 4276303
• Product Code: CIG
• UDI-Device Identifier: 00380740158422
• UDI-Public: (01)00380740158422(17)260131(10)66829UQ08
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 01/31/2026
• Device Catalogue Number: 04V51-31
• Device Lot Number: 66829UQ08
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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