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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC MAGNESIUM
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ABBOTT MANUFACTURING INC MAGNESIUM Back to Search Results
Catalog Number 03P68-31
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 Description
The customer observed falsely elevated magnesium results on the architect c16000 analyzer.The following data was provided: sid (b)(6) initial 2.90, repeat 0.9 mmol/l.There was no impact to patient management reported.
 
Manufacturer Narrative
On november 1, 2019, the suspect medical device was updated from 07d70-20 lot unknown to ln 03p68-31 lot 04425un19, both manufactured in irving, texas usa.An evaluation is in process and a follow up submission will be provided when the evaluation is complete.
 
Manufacturer Narrative
On november 1, 2019 the suspect medical device was updated from architect magnesium reagents ln 03p68-31 lot 04425un19 to architect c16000 analyzer ln 03l77-01 sn (b)(4) and manufacturer's report 1628664-2019-00715 was submitted to document this.All follow up information will be contained there.
 
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Brand Name
MAGNESIUM
Type of Device
MAGNESIUM
Manufacturer (Section D)
ABBOTT MANUFACTURING INC
1921 hurd drive
irving TX 75038
MDR Report Key9258517
MDR Text Key195147818
Report Number1628664-2019-00690
Device Sequence Number1
Product Code JGJ
Combination Product (y/n)N
PMA/PMN Number
K981791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 11/15/2019
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 Catalogue Number03P68-31
Device Lot Number04425UN19
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/07/2019
Initial Date FDA Received10/30/2019
Supplement Dates Manufacturer Received11/01/2019
11/01/2019
Supplement Dates FDA Received11/01/2019
11/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT C16000 ANALYZER; ARCHITECT C16000 ANALYZER; LN 03L77-01 SN (B)(4); LN 3L77-01 SN (B)(4)
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