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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM
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ABBOTT LABORATORIES MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM Back to Search Results
Catalog Number 03P68-31
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.Complete information for patient identifier = sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.
 
Event Description
The customer reported falsely elevated magnesium (mg) results occurring intermittently on one patient sample on the architect analyzer.The results provided were on (b)(6) 2021 sid (b)(6) initial = 2.20mg/dl / retest = >8.70mg/dl.There was no reported impact to patient management.
 
Manufacturer Narrative
After further evaluation, the suspect medical device was changed from magnesium, list number 03p68-31 in section d of this report to architect c4000, list number 02p24-40, with the manufacturing site remaining the same.Mdr number 3016438761-2021-00103-00 has been submitted and all further information will be documented under that mdr number.
 
Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.
 
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Brand Name
MAGNESIUM
Type of Device
PHOTOMETRIC METHOD, MAGNESIUM
Manufacturer (Section D)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
MDR Report Key11435105
MDR Text Key264290460
Report Number3016438761-2021-00084
Device Sequence Number1
Product Code JGJ
Combination Product (y/n)N
PMA/PMN Number
K181748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03P68-31
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC C4000 INTGR, 02P24-40, C402044; ARC C4000 INTGR, 02P24-40, C402044; ARC C4000 INTGR, 02P24-40, C402044
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