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

Model Number	6L45-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated total bilirubin results on architect c8000 processing module for one patient.The results provided were: initial=174.5 umol/l and 177.3 umol/l /repeated=normal (no actual results provided) laboratory reference range for total bilirubin=3.4 to 20.5 umol/l there was no reported impact to patient management.
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 elevated total bilirubin results on architect c8000 processing module for one patient.The results provided were: initial=174.5 umol/l and 177.3 umol/l /repeated=normal (no actual results provided) laboratory reference range for total bilirubin=3.4 to 20.5 umol/l there was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review for architect total bilirubin reagent ln 6l45, lot number 62175uq05.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.From the information provided by customer technical support, the false elevated results the customer observed, is due to the large quantity of bubbles being present in the reagent.Once these were removed, the sample was re-tested, and qc was run again.The sample result returned to normal, and qc was in range.The issue was resolved by troubleshooting.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect total bilirubin reagent, lot number 62175uq05.

• 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: 16619282
• Report Number: 3002809144-2023-00167
• Device Sequence Number: 20612494
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 10/31/2023
• Device Model Number: 6L45-22
• Device Catalogue Number: 06L45-22
• Device Lot Number: 62175UQ05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C16K PRC MOD, 03L77-01, (B)(6) ; ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Sex: Unknown