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

Catalog Number	04V51-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6) (2-month-old) / (b)(6) (4-day-old) / (b)(6) (2-month-old) - 3 total patients 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 decreased alinity c total bilirubin results generated on the alinity c processing module.The customer stated that they were aware of the insufficient sample volumes when testing the total bilirubin assay on infants.The sample volumes were below the requirements stated in the package insert.The following data was provided: total bilirubin results: sid (b)(6) (2-month-old); 2 samples taken on same day: 1st result =36 umol/l; 2nd result = 187 umol/l sid (b)(6) (4-day-old): result = 43 umol/l; previous day result = 144 umol/l; next day result = 143 umol/l sid (b)(6) (2-month-old): result = 7 umol/l; previous day result = 91 umol/l there was no impact to patient management reported.
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.A search by product lot did not identify an increase in complaint activity.The tracking and trending review by list number did not identify any related trends.The device history record did not identify any non-conformance's or deviations related to the lot number and complaint issue.Labeling was reviewed and found to adequately addresses the issue under review.In this case, the sample volumes were below the requirements stated in the package insert.As part of the troubleshooting the sample was rerun with sufficient sample the results were as expected.Based on the investigation, alinity c total bilirubin reagent lot 65300uq11 is performing as intended, no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported falsely decreased alinity c total bilirubin results generated on the alinity c processing module.The customer stated that they were aware of the insufficient sample volumes when testing the total bilirubin assay on infants.The sample volumes were below the requirements stated in the package insert.The following data was provided: total bilirubin results: sid (b)(6) (2-month-old); 2 samples taken on same day: 1st result =36 umol/l; 2nd result = 187 umol/l.Sid (b)(6) (4-day-old): result = 43 umol/l; previous day result = 144 umol/l; next day result = 143 umol/l.Sid (b)(6) (2-month-old): result = 7 umol/l; previous day result = 91 umol/l.There was no impact to patient management reported.

• 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: 19652435
• Report Number: 3002809144-2024-00191
• Device Sequence Number: 12488840
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: (01)00380740158415(17)250430(10)65300UQ11
• 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): 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): 08/14/2024

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: 04/30/2025
• Device Catalogue Number: 04V51-21
• Device Lot Number: 65300UQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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