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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT
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ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT Back to Search Results
Catalog Number 06L45-41
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2018
Event Type  malfunction  
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 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.
 
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.
 
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Brand Name
CLINICAL CHEMISTRY TOTAL BILIRUBIN
Type of Device
TOTAL BILIRUBIN REAGENT
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
MDR Report Key8034914
MDR Text Key127887661
Report Number1628664-2018-01982
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 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number06L45-41
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT C8000 ANALYZER; ARCHITECT C8000 ANALYZER; LN 01G06-11 SN (B)(4); LN 01G06-11 SN (B)(4)
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