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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2018
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.Mdr number 1628664-2018-01983 has been submitted for this issue that also involves the architect c8000 analyzer.An evaluation is in process.
Event or Problem Description
The customer observed falsely depressed results for a pediatric patient while using clinical chemistry total bilirubin reagents with the architect c8000 analyzer.The following data was provided.The customer uses normal range less than or equal to 1.9 ng/ml.Sid (b)(4), initial 0.7 ng/dl, repeat 6.8, 6.8 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was determined to not be the reagent.The suspect medical device was determined to be only the architect c8000 analyzer.Mdr number 1628664-2018-01983 was previously submitted and all further information will be documented under that mdr number.

• 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: 8034914
• Report Number: 1628664-2018-01982
• Device Sequence Number: 1463623
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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 Catalogue Number: 06L45-41
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 11/19/2018
• 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 C8000 ANALYZER; ARCHITECT C8000 ANALYZER; LN 01G06-11 SN (B)(4); LN 01G06-11 SN (B)(4)