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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES CLINICAL CHEMISTRY TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT
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ABBOTT LABORATORIES CLINICAL CHEMISTRY TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT Back to Search Results
Catalog Number 06L45-41
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2018
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed multiple falsely elevated total bilirubin results while using the clinical chemistry total bilirubin reagents.The following data was provided.(b)(6).No impact to patient management was reported.
 
Manufacturer Narrative
The medical device manufacturer was incorrect in manufacturer name, city and state and mfr site/ report source for this issue.Mdr number 1628664-2018-00136 has been submitted and all further information will be documented under that mdr number.
 
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Brand Name
CLINICAL CHEMISTRY TOTAL BILIRUBIN
Type of Device
TOTAL BILIRUBIN REAGENT
Manufacturer (Section D)
ABBOTT LABORATORIES
100 abbott park road
abbott park IL 60064 3500
MDR Report Key7342841
MDR Text Key103034295
Report Number1415939-2018-00045
Device Sequence Number1
Product Code CIG
UDI-Device Identifier00380740011383
UDI-Public00380740011383
Combination Product (y/n)N
PMA/PMN Number
K060574
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number06L45-41
Device Lot Number50094UQ09
Date Manufacturer Received04/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT C8000 ANALYZER; ARCHITECT C8000 ANALYZER; LIST NUMBER 01G06-11; LIST NUMBER 01G06-11; SERIAL NUMBER (B)(4); SERIAL NUMBER (B)(4)
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