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

Model Number 04V5121

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Event 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.

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.

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.

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
• Type of Device: 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
• MDR Text Key: 308247651
• Report Number: 3002809144-2022-00447
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: 00380740158415
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K121985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6)