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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH CARBON DIOXIDE; ENZYMATIC, CARBON-DIOXIDE
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ABBOTT GMBH CARBON DIOXIDE; ENZYMATIC, CARBON-DIOXIDE Back to Search Results
Catalog Number 03L80-32
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2024
Event Type  malfunction  
Event Description
The customer observed falsely elevated co2 results generated on the architect c16000 processing module for one sample.The customer repeated the sample on another architect and the results were lower.The following data was provided: initial result = 32 mmol/l repeat results= 25 and 26 mmol/l 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
CARBON DIOXIDE
Type of Device
ENZYMATIC, CARBON-DIOXIDE
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 Key18789983
MDR Text Key336405124
Report Number3002809144-2024-00048
Device Sequence Number1
Product Code KHS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K060295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03L80-32
Device Lot Number64248UQ04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC C16K PRC MOD, 03L77-01, C1601195
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