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	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 phone: complete phone number is (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated architect total bilirubin and when repeated with another bottle of reagent the results were normal.The customer provided the following data: (customer¿s reference range was 3.4-20.5umol/l).Sample 1 initial result was 26.21, repeat result was 10.26.Sample 2 initial result was 22.19, repeat result was 5.73.Sample 3 initial result was 28.71, repeat result was 5.44.Sample 4 initial result was 27.12, repeat result was 11.Sample 5 initial result was 56, repeat result was 37.8.Per the customer, the results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
H6 - adverse event problem: d code corrected.
Event or Problem Description
The customer reported falsely elevated architect total bilirubin and when repeated with another bottle of reagent the results were normal.The customer provided the following data: (customer¿s reference range was 3.4-20.5umol/l).Sample 1 initial result was 26.21, repeat result was 10.26.Sample 2 initial result was 22.19, repeat result was 5.73.Sample 3 initial result was 28.71, repeat result was 5.44.Sample 4 initial result was 27.12, repeat result was 11.Sample 5 initial result was 56, repeat result was 37.8.Per the customer, the results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely elevated architect total bilirubin and when repeated with another bottle of reagent the results were normal.The customer provided the following data: (customer¿s reference range was 3.4-20.5umol/l) sample 1 initial result was 26.21, repeat result was 10.26 sample 2 initial result was 22.19, repeat result was 5.73 sample 3 initial result was 28.71, repeat result was 5.44 sample 4 initial result was 27.12, repeat result was 11 sample 5 initial result was 56, repeat result was 37.8 per the customer, the results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.
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.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot did not identify an increase in complaint activity for the complaint lot.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect total bilirubin reagent lot number 62175uq05 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: 17557468
• Report Number: 3002809144-2023-00357
• Device Sequence Number: 3435052
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2023

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 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: 08/01/2023
• Supplement Date Received by Manufacturer: 08/28/2023; 09/05/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 08/31/2023; 09/05/2023
• 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
• 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); ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Sex: Unknown