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

Catalog Number	07P32-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
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.An evaluation is in process.
Event or Problem Description
The customer observed falsely depressed results while using total bilirubin reagents.The following data was provided.Sid (b)(6) initial and repeat results read 0.481 mg/dl (reported as less than 1.50 mg/dl).Repeat using another analyzer 2.67, 2.74 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, instrument log review, and labeling review.Returns were not available.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Log review did not identify any issues that contributed to the customer issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• 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: 7684141
• Report Number: 1628664-2018-00268
• Device Sequence Number: 16493301
• Product Code: CIG
• UDI-Device Identifier: 00380740129033
• UDI-Public: 00380740129033
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/05/2018

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: 08/31/2018
• Device Catalogue Number: 07P32-21
• Device Lot Number: 50973UQ03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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: ARCHITECT C16000 ANALYZER; ARCHITECT C16000 ANALYZER; LN 03L77-01; LN 03L77-01 SN (B)(4) ; SN (B)(4)