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

Catalog Number	06L45-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
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
The customer stated that a falsely decreased architect total bilirubin result was generated for a newborn patient (sample id (b)(6)) on (b)(6) 2017.Initial testing was 12.96 mg/dl.Repeat testing was 0.57 mg/dl which is suspected to be falsely decreased.The initial high result was verified by 1:1 dilution testing (12.10 mg/dl).The customer stated that it is possible that the second value was generated after the sample sat for 30 minutes at room temperature under the influence of light which is not in accordance with sample handling instructions in the reagent package insert.The customer will attempt to retrace the handling of this sample.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
No customer returns were available.Investigation of the customer issue included a review of the complaint text, a search for similar complaints and a review of labeling.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.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: BILIRUBIN
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7001262
• Report Number: 1628664-2017-00424
• Device Sequence Number: 19083960
• Product Code: CIG
• UDI-Device Identifier: 00380740129033
• UDI-Public: 00380740129033
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: 10/31/2018
• Device Catalogue Number: 06L45-21
• Device Lot Number: 51206UQ05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1