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

Model Number	6L45-42
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Based on the complaint data and this investigation, the most likely cause of the total bilirubin patient results issue is bubbles in the reagent.The analysis by customer service shows bubbles and interference with the liquid level detection system.Ticket and trending review did not identify any trends for the likely cause.Device history record review did not identify any non-conformances or deviations related to the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the total bilirubin reagent lot 59669uq04 was identified.Use error may have contributed to the customer¿s issue as bubbles in the reagent are specifically cautioned against in the assay package insert.In addition, the package insert provides instructions not to mix this reagent due to its propensity to generate bubbles due to required surfactants in the formulation.Patient identifier: (b)(6).Phone number: (b)(6).
Event or Problem Description
The customer observed a falsely elevated total bilirubin result generated on an architect c16000 processing module for one patient.Sid (b)(6) initial result = 326.8 umol/l (result was released from lab).The patient was redrawn, sid (b)(6) result = 6 umol/l.The lab repeated the original sample, sid (b)(6).The repeat result = 16 umol/l.Additionally, the customer had a qc flier during the morning.Qc run: qc l2range 41.770-47.50, result 189.50.All other qc levels were in range.The qc was repeated and was in range, 43.60.As part of troubleshooting, the logs were reviewed and found three aspiration that were indicative of bubbles, two caused exceptions and the third was the flier.There was no impact to patient management reported.

• 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: 13625040
• Report Number: 3002809144-2022-00068
• Device Sequence Number: 12043498
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: 00380740174972
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 02/28/2022

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: 09/30/2022
• Device Model Number: 6L45-42
• Device Catalogue Number: 06L45-42
• Device Lot Number: 59669UQ04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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 C16K PRC MOD, 03L77-01, C1600670
• Patient Sex: Unknown