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	05/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The literature article by melville, anna and thomas, sunethra devika c ¿paraprotein interference of automated total bilirubin measurement¿ documented paraprotein interference in the alinity c total bilirubin assay.The author documented falsely depressed alinity c total bilirubin results generated on the alinity c instrument for a (b)(6) male patient.The initial result was <9 umol/l (reference interval 4 to 20 umol/l), all other routine results were normal except total protein 120 g/l (reference interval 60 to 85 g/l), albumin 38 g/l (reference interval 39 to 50 g/l) and globulin 82 g/l (reference interval 23 to 39 g/l).The patient¿s previous results for bilirubin were <9 umol/l on several occasions, however, 12 months prior the bilirubin result on roche platform was 54 umol/l, other results total protein 116 g/l (reference interval 66 to 83 g/l), albumin 37 g/l and globulin 79 g/l).Additionally, the findings of the study documented that the presence of paraprotein can affect the measured concentration of bilirubin using the abbott alinity assay.Furthermore, igm appears to exert a more significant effect on bilirubin measurement.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Data and information provided was reviewed and support the complaint issue.Return testing was not performed as returns were not available.Device history record review was performed on list 04v51, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Labeling in the total bilirubin package insert and the alinity ci series operations manual advises the operator and physician to review all results from the patient along with clinical data, other tests, symptoms and clinical evaluation to properly evaluate the applicability of test results.The findings of the study documented that the presence of paraprotein can affect the measured concentration of bilirubin using the abbott alinity assay.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.A deficiency was not identified.

• 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: 14463691
• Report Number: 3002809144-2022-00173
• Device Sequence Number: 14595000
• Product Code: CIG
• UDI-Device Identifier: 00380740158415
• UDI-Public: 00380740158415
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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 Model Number: 04V5121
• Device Catalogue Number: 04V51-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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, 210UNKNOWND14; ALNTY C PROCESSING MODU, 03R67-01, 210UNKNOWND14
• Patient Age: 45 YR
• Patient Sex: Male