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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C MAGNESIUM REAGENT KIT; PHOTOMETRIC METHOD, MAGNESIUM

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ABBOTT GMBH ALINITY C MAGNESIUM REAGENT KIT; PHOTOMETRIC METHOD, MAGNESIUM Back to Search Results
Catalog Number 08P19-20
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2024
Event Type  malfunction  
Event Description
The customer observed falsely elevated alinity c magnesium results generated on the alinity c processing module for one patient.On (b)(6) 2024, the initial result for sid (b)(6) was 6.34 mg/dl (normal reference range 1.6 - 2.6 mg/dl).The physician questioned the result and new sample was drawn.The result of the second sample from the same patient was 2.46 mg/dl.No impact to patient management was reported.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
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Brand Name
ALINITY C MAGNESIUM REAGENT KIT
Type of Device
PHOTOMETRIC METHOD, MAGNESIUM
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM   65205
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18832427
MDR Text Key336882219
Report Number3002809144-2024-00055
Device Sequence Number1
Product Code JGJ
UDI-Device Identifier00380740121839
UDI-Public00380740121839
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number08P19-20
Device Lot Number57143UD00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALNTY C PROCESSING MODU, 03R67-01, AC02727
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