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

Model Number	6L45-41
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, design history review, a search for similar complaints, and a review of labeling.Return material was not available.A design history review did not find any non-conformances or deviations with the lot number in question.A review of tracking and trending did not identify an adverse trend for issue observed by the customer.No other similar complaints were identified with this reagent lot number.Labeling was reviewed and found to be adequate.Based on this investigation this appears to be a sample specific issue.Based on the available information no deficiency of the clinical chemistry bilirubin assay, reagent list number 06l45, lot 50182uq10, was identified.An evaluation is in-process.
Event or Problem Description
The customer observed falsely elevated bilirubin results while using the clinical chemistry total bilirubin assay.The customer provided the following example data from (b)(6) 2017: patient 1: initial 1.4, retest 0.5.Patient 2: 2, retest 1.1.Patient 3: 1.3, retest 0.4.No adverse impact to patient management was reported.

• Brand Name: CLINICAL CHEMISTRY TOTAL BILIRUBIN
• Common Device Name: BILIRUBIN
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6791660
• Report Number: 1628664-2017-00308
• Device Sequence Number: 11008839
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: (01)00380740011383(17)180331(10)50182UQ10
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2017

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: 03/31/2018
• Device Model Number: 6L45-41
• Device Catalogue Number: 07P32-21
• Device Lot Number: 50182UQ10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1