MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

Catalog Number	06L45-41
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier: (b)(6).No further patient information was provided.
Event or Problem Description
The customer reported imprecise and falsely elevated architect total bilirubin results for one patient sample.The sample was tested multiple times on multiple analyzers generating the following results: (b)(6).The customer uses a normal range of less than 20 umol/l.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Update 19jun2018: patient information: patient's age and gender were provided.The customer provided multiple reaction graphs from the suspect sample.Review of these graphs found the initial absorbance, when only the sample and the r1 reagent are present, showed higher than expected absorbance values.The higher absorbance values may be due to an interferent present in the sample.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 likely cause lot 54261uq01.Using worldwide field data, the historical performance of reagent lot 54261uq01 was reviewed.This review found the lot is performing acceptably and similar to other reagent lots in the field.Manufacturing documentation for the likely cause lot 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 architect total bilirubin assay was identified.

• Brand Name: CLINICAL CHEMISTRY TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7534000
• Report Number: 1628664-2018-00199
• Device Sequence Number: 1652774
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: 06/30/2019
• Device Catalogue Number: 06L45-41
• Device Lot Number: 52461UQ01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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: (B)(4); (B)(4); ARCHITECT C16000 ANALYZER,; ARCHITECT C16000 ANALYZER,; LIST 03L77-01, SERIAL (B)(4); LIST 03L77-01, SERIAL (B)(4)