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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
Model Number 3L80-22
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2021
Event Type  malfunction  
Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 58505uq11.Trending review determined no trend identified for falsely depressed results for the product.Return testing was not completed as returns were not available.Maintenance of the non-abbott water quality system and re-establishing the required product water quality to the instrument corrected the results issue.Results were returned to expected levels.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.The device history record review identified no non-conformances or deviations related to the complaint issue.A review of the labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect carbon dioxide reagent, lot number 58505uq11 was identified.
 
Event Description
The customer reported a high anion gap for a patient while using the architect c4000 analyzer.The following data was provided (normal range anion gap: 11-16): sodium = current = 133 mmol/l / previous = 143 mmol/l.Potassium = current = 4.6 mmol/l / previous = 5.1 mmol/l.Chloride = current = 107 mmol/l / previous = 113 mmol/l.Bicarbonate (co2) = current = 17 mmol/l / previous = 23 mmol/l.Anion gap = current = 18 / previous = 12.The anion gap is calculated measurement from sodium, chloride and bicarbonate (co2).There was no impact to patient management reported.
 
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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
christian lee
100 abbott park road
dept. 09b9, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key11952066
MDR Text Key273663758
Report Number3002809144-2021-00356
Device Sequence Number1
Product Code KHS
UDI-Device Identifier00380740161521
UDI-Public00380740161521
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060295
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 06/07/2021
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 Expiration Date12/31/2021
Device Model Number3L80-22
Device Catalogue Number03L80-22
Device Lot Number58505UQ11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/13/2021
Initial Date FDA Received06/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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