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

Catalog Number	06L45-42
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2025
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.
Event or Problem Description
The customer observed falsely depressed total bilirubin results for one sample.The customer stated that there was instrument error message ¿1051 unable to calculate result, absorbance exceeded optical limits¿ and the instrument when to auto-dilution and the result was reported out of the lab.The following result was provided: total bilirubin: auto-dilution result that was reported out was <0.1 mg/dl, rerun was 0.5 mg/dl (reference range: 0.1-1.2 mg/dl).No impact to patient management was reported.
Event or Problem Description
The customer observed falsely depressed total bilirubin results for one sample.The customer stated that there was instrument error message ¿1051 unable to calculate result, absorbance exceeded optical limits¿ and the instrument when to auto-dilution and the result was reported out of the lab.The following result was provided: total bilirubin: auto-dilution result that was reported out was <0.1 mg/dl, rerun was 0.5 mg/dl (reference range: 0.1-1.2 mg/dl).No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from total bilirubin, list number 06l45-42 and manufacturing site wiesbaden, to the architect c8000 processing module list number 01g06-11, and manufacturing site of irving, texas.Mdr number 3016438761-2025-00487 has been submitted, and all further information will be documented under that mdr number.

• Brand Name: ARCHITECT 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: 22715709
• Report Number: 3002809144-2025-00258
• Device Sequence Number: 13044651
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: (01)00380740174972(17)260630(10)67014UQ01
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/21/2025

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 Catalogue Number: 06L45-42
• Device Lot Number: 67014UQ01
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 C8 PROC MOD, 01G06-11, C804158; ARC C8 PROC MOD, 01G06-11, C804158
• Patient Sex: Unknown