MAUDE Adverse Event Report: ABBOTT GMBH TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	06L45-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6), complete entry for section e1 - phone number: (b)(6).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 a falsely elevated total bilirubin on the architect c4000 processing module for one patient.The following results were provided (reference range, total bilirubin, 0.20 to 1.20 mg/dl): on (b)(6) 2024, sid (b)(6), initial total bilirubin result= 26.36 mg/dl; repeat result= 0.37 mg/dl.There was no impact to patient management reported.
Event or Problem Description
The customer observed a falsely elevated total bilirubin on the architect c4000 processing module for one patient.The following results were provided (reference range, total bilirubin, 0.20 to 1.20 mg/dl): (b)(6) 2024, sid (b)(6) , initial total bilirubin result= 26.36 mg/dl; repeat result= 0.37 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from total bilirubin, list number 06l45-22, and manufacturing site abbott gmbh, wiesbaden to architect c4000, list number 02p24-01, and manufacturing site abbott laboratories, irving.Mdr number 3016438761-2025-00037 has been submitted and all further information will be documented under that mdr number.

• Brand Name: TOTAL BILIRUBIN
• 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: 21114760
• Report Number: 3002809144-2025-00005
• Device Sequence Number: 7436330
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: (01)00380740174965(17)250731(10)65824UQ02
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/17/2025

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: 07/31/2025
• Device Catalogue Number: 06L45-22
• Device Lot Number: 65824UQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2024
• 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: ARC C4 PROC MOD, 02P24-01, (B)(6); ARC C4 PROC MOD, 02P24-01, (B)(6)
• Patient Sex: Unknown