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

Catalog Number	06L45-41
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2018
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.
Event or Problem Description
A physician questioned an architect total bilirubin result of 0.5 mg/dl for a neonatal patient.The sample was short volume but no error message was generated.A new sample was drawn and the architect total bilirubin result was 11.8 mg/dl.The customer stated no adverse impact to patient management occurred.
Additional Manufacturer Narrative
Quality control (qc) results for 3 levels of controls were within expected ranges before and after the issue.The qc and patient results were tested on the same reagent cartridge.No issues were reported with controls or other patient results.The lls log showed no abnormal step patterns for the r1 reagent and r2 reagent pipettors during the analysis of the suspect patient sample.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Based on the available information, no product deficiency 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: 7731270
• Report Number: 1628664-2018-00738
• Device Sequence Number: 16541264
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K060574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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 C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LIST 02P24-40, SERIAL (B)(4); LIST 02P24-40, SERIAL (B)(4); ARCHITECT C4000 ANALYZER; LIST 02P24-40, (B)(4)