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

Model Number 04V5121

Device Problem High Test Results (2457)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity c total bilirubin results for eight patients generated on the alinity c analyzer.The samples were repeated on the roche analyzer which generated normal results.The customer then ran controls on the alinity c analyzer, and the controls were also out of range high.The customer performed daily maintenance, repeated the controls and controls were back in range.The customer repeated the eight samples again and the results were within the normal range.The customer provided the following data for 3 patients: normal range 3.4 to 20.5 umol/l on (b)(6) 2022 sid (b)(6) initial result = 165.3 umol/l, repeat result post maintenance = 14.2 umol/l, roche result = 13.3 umol/l on (b)(6) 2022 sid (b)(6) initial result = 177.4 umol/l, repeat result post maintenance = 4.6 umol/l, roche result = 3.2 umol/l on (b)(6) 2022 (b)(6) initial result = 67.3 umol/l, repeat result post maintenance = 6.4 umol/l, roche result = 5.4 umol/l no impact to patient management was reported.

Manufacturer Narrative

Patient identifier: sids are: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity c total bilirubin results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review, and labeling 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.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 60971uq11 and the complaint issue.The overall performance of the alinity c total bilirubin assay was reviewed using field data from customers worldwide.The median population result for lot 60971uq11 is within the established baseline, indicating the reagent lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer's issue.With the information provided in the complaint and this investigation, the exact cause of the shifted alinity c total bilirubin results cannot be determined.However, daily maintenance accomplishes several actions that may be a cause of shifted results.Pipettor lines are flushed removing bubbles and accumulated debris if present.The incubator water bath is exchanged along with cleaning of the pipettor probes and mixers.Each of these items are potential sources of error when results are observed to be impacted.Based on our investigation, no systemic issue or deficiency with the alinity c total bilirubin assay for lot 60971uq11 was identified.

• 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: 15544588
• MDR Text Key: 303559636
• Report Number: 3002809144-2022-00349
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: 00380740158415
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 04V5121
• Device Catalogue Number: 04V51-21
• Device Lot Number: 60971UQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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)