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

Model Number	04V5121
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely depressed alinity c total bilirubin results for a patient sample when compared to other instrument platforms.The following data was provided: patient result on alinity c: on (b)(6) 2022 at 19:20: total bilirubin: 10.5 umol/l.Retest on (b)(6) 2022 at 10:34: total bilirubin: 10.8 umol/l.Normal range: total bilirubin: 3.4 - 20.5 umol/l.Patient result on dxc700: on (b)(6) 2022 at 9:08: total bilirubin: 23.62 umol/l / direct bilirubin: 4.94 umol/l.Normal range: total bilirubin: < 17 umol/l.Patient result on bt450: on (b)(6) 2022 at 07:14: total bilirubin: 22.36 umol/l normal range: total bilirubin: 8.5 - 17 umol/l there was no impact to patient management reported.
Additional Manufacturer Narrative
All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Updated d4 - lot no: old: unknown / updated new: 60776uq10.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed alinity c total bilirubin results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A review of tickets determined there is normal complaint activity for lot number 60776uq10.A review of tracking and trending data did not identify any related trends for the product for the issue.The device history records were reviewed and did not identify any non-conformances or deviations associated with lot 60776uq10 and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for alinity c total bilirubin reagent lot 60776uq10.H4 - device mfg date - initial: blank / current: 12/10/2022.D4 - expiration date - initial: blank / current: 03/31/2023.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16011601
• Report Number: 3002809144-2022-00447
• Device Sequence Number: 6371353
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: 00380740158415
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 03/21/2023

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: 03/31/2023
• Device Model Number: 04V5121
• Device Catalogue Number: 04V51-21
• Device Lot Number: 60776UQ10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 03/02/2023; 03/10/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/03/2023; 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown