MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

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	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of tickets determined normal complaint activity for lot 55406uq07 and no trends for the issue for the product.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the total bilirubin reagent and architect system operations manual product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect total bilirubin reagent, lot 55406uq07.This issue was previously reported under mdr number 1415939-2020-00031.The suspect medical device architect total bilirubin reagent, list number 06l45-41, lot 55406uq07, was filed on the incorrect manufacturing site abbott laboratories, (b)(4).The correct manufacturing site is abbott laboratories (b)(4).
Event or Problem Description
The customer observed erratic total bilirubin results on one patient on the architect c8000 analyzer, serial number (b)(4).The following data was provided: total bilirubin = 5.4mmol/l, direct bilirubin = 6.6.The sample was tested on another architect c8000, serial number (b)(4) - total bilirubin = 6.5mmol/l, direct bilirubin = 7.0.The sample was then retested on sn (b)(4) - total bilirubin = 1.9mmol/l, direct bilirubin = 5.9.There was no impact to patient management reported.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10028824
• Report Number: 3016438761-2020-00062
• Device Sequence Number: 766021
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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: 12/31/2020
• Device Model Number: 6L45-41
• Device Catalogue Number: 06L45-41
• Device Lot Number: 55406UQ07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1