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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
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.
 
Event Description
The account generated a false elevated architect magnesium (7.33 mg/dl) that repeated on another analyzer (2.34, 2.39 mg/dl).No impact to patient management was reported.No specific patient information was provided.
 
Manufacturer Narrative
The product evaluation of the customer issue included a search for similar complaints with reagent lots, a review of instrument logs, a review of labelling.No adverse trend, non-statistical trends, non-conformances, potential non-conformances, or deviations were identified for the customer's issue.Instrument logs were reviewed and 0550 cuvette washing not completed, hardware failure or user pressed stop.Promptly perform the wash cuvettes procedure were noted in instrument notification text.A review of the product labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.
 
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Brand Name
CLINICAL CHEMISTRY MAGNESIUM
Type of Device
MAGNESIUM
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
MDR Report Key8193074
MDR Text Key131311470
Report Number1628664-2018-02180
Device Sequence Number1
Product Code JGJ
UDI-Device Identifier00380740012939
UDI-Public00380740012939
Combination Product (y/n)N
PMA/PMN Number
K981791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/01/2019
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
Device Operator Health Professional
Device Expiration Date06/11/2020
Device Catalogue Number07D70-31
Device Lot Number33785UN18
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/30/2018
Initial Date FDA Received12/22/2018
Supplement Dates Manufacturer Received01/11/2019
Supplement Dates FDA Received02/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT C8000 LIST 01G06-11; ARCHITECT C8000 LIST 01G06-11; SERIAL (B)(4); SERIAL (B)(4)
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