MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C TOTAL BILIRUBIN REAGENT KIT; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	04V51-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed alinity c total bilirubin results generated on the alinty c processing module for two samples.Also, instrument error messages were observed on the alinity c module for linearity errors for total bilirubin.The following data was provided: (b)(6) 2024, sid (b)(6), tbili <0.1 mg/dl, re-measured 0.3 mg/dl.Sid (b)(6), tbili <0.1 mg/dl, re-measured 0.5 mg/dl.Normal ranges: tbili <1.2 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.
Event or Problem Description
The customer observed falsely depressed alinity c total bilirubin results generated on the alinty c processing module for two samples.Also, instrument error messages were observed on the alinity c module for linearity errors for total bilirubin.The following data was provided: (b)(6) 2024 sid (b)(6) tbili <0.1 mg/dl, re-measured 0.3 mg/dl.Sid (b)(6) tbili <0.1 mg/dl, re-measured 0.5 mg/dl.Normal ranges tbili <1.2 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Updated information: d.4 lot# updated from 'unknown' to 66178uq04.D.4 primary udi number updated.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data 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 indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the alinity c total bilirubin reagents in the field was reviewed using data gathered from customers worldwide.The patient median values obtained with the complaint lot 66178uq04 is within established limits and thus comparable to the historical lot performance, which confirms no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c total bilirubin reagent lot 66178uq04 was identified.

• Brand Name: ALINITY C TOTAL BILIRUBIN REAGENT KIT
• 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: 20495169
• Report Number: 3002809144-2024-00302
• Device Sequence Number: 3615835
• Product Code: CIG
• UDI-Device Identifier: 00380740158422
• UDI-Public: (01)00380740158422(17)250930(10)66178UQ04
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/03/2024

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: 09/30/2025
• Device Catalogue Number: 04V51-31
• Device Lot Number: 66178UQ04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown