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

Model Number	6L45-42
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely decreased total bilirubin result generated on the architect c4000 analyzer on a patient.Results provided: (b)(6) 2022 (b)(6) =0.92 mg/dl, another architect = 1.25 mg/dl (normal range: 0.2-1.20 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.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 60072uq07.Trending review determined no trends for falsely depressed results for the product.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no deficiency of the architect total bilirubin reagent lot number 60072uq07 was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13681482
• Report Number: 3002809144-2022-00073
• Device Sequence Number: 14796404
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: 00380740174972
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/25/2022

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: 12/31/2022
• Device Model Number: 6L45-42
• Device Catalogue Number: 06L45-42
• Device Lot Number: 60072UQ07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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 C4000 INTGR, 02P24-40, C400758; ARC C4000 INTGR, 02P24-40, C400758
• Patient Sex: Unknown