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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM
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ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM Back to Search Results
Model Number 03P6822
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  malfunction  
Manufacturer Narrative
There was no further patient information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed falsely elevated magnesium results on architect c4000 processing module for multiple patients.The few results examples provided were: on (b)(6) 2021 patient 1: initial=3.9 mmol/l /repeated=0.71 mmol/l.Patient 2: initial=3.2 mmol/l /repeated=0.67 mmol/l there was no reported impact to patient management.
 
Manufacturer Narrative
Cross reference mdr for likely cause changed; magnesium to architect c4000 processing module, list 02p24-40, 3016438761-2021-00323-00.
 
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Brand Name
MAGNESIUM
Type of Device
PHOTOMETRIC METHOD, MAGNESIUM
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key12378047
MDR Text Key268493876
Report Number3002809144-2021-00527
Device Sequence Number1
Product Code JGJ
UDI-Device Identifier00380740161620
UDI-Public00380740161620
Combination Product (y/n)N
PMA/PMN Number
K181748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03P6822
Device Catalogue Number03P68-22
Device Lot Number65953UN21
Was Device Available for Evaluation? No
Date Manufacturer Received08/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC C4000 INTGR, (B)(4); ARC C4000 INTGR, (B)(4); ARC C4000 INTGR, (B)(4)
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