MAUDE Adverse Event Report: ABBOTT GMBH CLINICAL CHEMISTRY TOTAL BILIRUBIN

Model Number	04V5131
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer obtained a falsely elevated alinity c total bilirubin result for a patient with waldenstroms.Sample id: (b)(6) generated 33 umol/l on the alinity, 5 umol/l on roche and 8umol/l on radiometer abl90.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of the data provided by the customer indicates the patient sample was initially analyzed on 02-feb-2020 with a result of 8.8 umol/ l generated.This report shows a processing code of d, indicating a diluted sample, rather than an undiluted sample was analyzed.The suspect sample was analyzed on 04-february-2020 with the 33 umol/l result.However, this sample was not diluted.The patient is noted to have waldenstrom macroglobulinemia.The test results show the total protein at 105 to 109 g/l.Review of two literature articles, waldenstrom macroglobulinemia and artifactual hyperbilirubinemia due to paraprotein interference, indicates waldenstrom macroglobulinemia is characterized by high protein and paraprotein levels.This contributes to an increased serum viscosity; higher than what normal patients would exhibit.This may contribute to a pipetting inconsistency or a sample affinity for the sample probe.Review of complaint activity did not identify any trends for the total bilirubin assay and no other complaints were identified related to the complaint issue for reagent lot 55441uq09.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the alinity c total bilirubin assay was identified.

• Brand Name: CLINICAL CHEMISTRY TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9740794
• Report Number: 3002809144-2020-00136
• Device Sequence Number: 1815345
• Product Code: CIG
• UDI-Device Identifier: 00380740158422
• UDI-Public: 00380740158422
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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: 05/31/2020
• Device Model Number: 04V5131
• Device Catalogue Number: 04V51-31
• Device Lot Number: 55441UQ09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/09/2020
• 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: ALINITY C PROCESSING MODULE, LIST 03R67-01; ALINITY C PROCESSING MODULE, LIST 03R67-01; SERIAL (B)(4) ; SERIAL (B)(4)