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	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely decreased alinity c total bilirubin (tbil) result for one patient sample when tested with serum and plasma.The following data was provided: on (b)(6) 2023 sid: (b)(6) (pediatric patient): serum tbil result = 286.4 umol/l / edta plasma tbil result = 211.4 umol/l / repeat tbil result = 269.7 umol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
All available patient information was included.Section g1 contact information was updated to reflect the current contact (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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.A ticket search by product lot number 64272uq05 found normal complaint activity.A review of ticket trending did not identify any related trends for the product for the issue.The device history review did not identify any non-conformances or deviations related to the lot number and complaint issue.Labeling was reviewed and found to adequately address the issue under review.As part of the troubleshooting, the sample was repeated on the same reagent lot multiple times and generated similar result as the first run.In addition, the internal quality control was performing as expected.No additional issues were identified.Based on the investigation, no systemic issue or product deficiency of the alinity c total bilirubin reagent lot 64272uq05 was identified.
Event or Problem Description
The customer reported a falsely decreased alinity c total bilirubin (tbil) result for one patient sample when tested with serum and plasma.The following data was provided: on 02oct2023 sid (b)(6) (pediatric patient): serum tbil result = 286.4 umol/l / edta plasma tbil result = 211.4 umol/l / repeat tbil result = 269.7 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: 17895198
• Report Number: 3002809144-2023-00423
• Device Sequence Number: 7007033
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: 00380740158415
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 12/06/2023

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: 10/31/2024
• Device Catalogue Number: 04V51-21
• Device Lot Number: 64272UQ05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• 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