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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM
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ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM Back to Search Results
Catalog Number 07D70-31
Medical Device Problem Code High Test Results (2457)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
 
Event or Problem Description
The customer observed falsely elevated magnesium results on the architect c16000 analyzer.The following data was provided (mg/dl): patient 1 initial 7.5, repeat 2.1; patient 2 initial 6.0, repeat 2.3.There was no impact to patient management reported.
 
Additional Manufacturer Narrative
On 4july2018, the suspect medical device was updated to the architect analyzer.See 1628664-2018-00256 for any further investigation and information.
 
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Brand Name
CLINICAL CHEMISTRY MAGNESIUM
Common Device Name
MAGNESIUM
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
MDR Report Key7639579
Report Number1628664-2018-00247
Device Sequence Number1424718
Product Code JGJ
UDI-Device Identifier00380740012939
UDI-Public00380740012939
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K981791
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 07/19/2018
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 Number07D70-31
Device Lot Number99640UN18
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 06/25/2018
Supplement Date Received by Manufacturer07/04/2018
Initial Report FDA Received Date06/26/2018
Supplement Report FDA Received Date07/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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