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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C CO2; CARBON DIOXIDE
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ABBOTT GERMANY ALINITY C CO2; CARBON DIOXIDE Back to Search Results
Catalog Number 07P72-20
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2019
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no specific patient information was provided by the customer.
 
Event Description
The customer reported a falsely elevated alinity co2 result.Sample id (b)(6) generated 31.7 mmol/l and retest 25.9 mmol/l.The customer uses a normal range of 22 to 29 mmol/l (meq/l).No impact to patient management was reported.
 
Event Description
The customer further reported a shift in co2 results and provided the following results.Sample id (b)(6): 28.8 meq/l, 21.4 meq/l and 21 meq/l on second analyzer.Sample id (b)(6): 17.4 meq/l, 15.3 meq/l.Sample id (b)(6): 28.7 mmol/l, 24.4 mmol/l.Sample id (b)(6): 35.6 mmol/l, 31.0 mmol/l.Multiple additional results were provided that ranged from 13.8 to 36.8 mmol/l and retests on an alternate alinity ranged from 10.7 to 32.2 mmol/l.
 
Manufacturer Narrative
No further updates were necessary.
 
Manufacturer Narrative
Complete information for correction/removal reporting number = 3002809144-10/24/19-009-r the investigation into this matter found that the amount of co2 absorbed was higher with increased reagent carousel rotation and when the volume of the reagent in the cartridge is reduced.This phenomenon could be detected as a shift in qc and also incorrect patient results.A product recall letter was sent to all customers who have received shipments of the impacted lots of the alinity c carbon dioxide reagent kit.The letter instructs the following: 1) immediately discontinue use of the alinity c carbon dioxide 15000t kit and destroy any remaining inventory as existing modes of control are not effective for the large cartridge.2) run two levels of co2 controls every hour with the use of the current alinity c carbon dioxide 3000t kit, instead of every 24 hours, and perform assay calibration as needed to minimize the potential to generate incorrect results.All current inventory of alinity c carbon dioxide (ln 07p7220), will be reworked to include a kit stuffer instructing customers to run qc every hour.In future lots of the alinity c carbon dioxide 3000t kit, the reagent cartridge fill volume will be increased from 12.7 ml to 20.7 ml, which has been confirmed to minimize co2 absorption.
 
Event Description
The customer provided the following additional discrepant results.Sample id (b)(6) : 29.8 and 26.1 mmol/l.Sample id (b)(6) 29.4 and 26.6 mmol/l.Sample id (b)(6) 30.6 and 28.9 mmol/l.Sample id (b)(6) 30.1 and 27.6 mmol/l.Sample id (b)(6) : 30.2 and 27.2 mmol/l.Sample id (b)(6) 32.9 and 24.9 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.Patient identifier: multiple = (b)(6).Patient information: no specific patient information was provided.
 
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Brand Name
ALINITY C CO2
Type of Device
CARBON DIOXIDE
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key8551864
MDR Text Key143841268
Report Number3002809144-2019-00247
Device Sequence Number1
Product Code KHS
UDI-Device Identifier00380740121594
UDI-Public00380740121594
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Catalogue Number07P72-20
Device Lot Number53069UQ05
Was Device Available for Evaluation? No
Date Manufacturer Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number3002809144-10/24/19-009R
Patient Sequence Number1
Treatment
ALINITY C ANALYZER, LIST 3R67-01,; ALINITY C ANALYZER, LIST 3R67-01,; ALINITY C ANALYZER, LIST 3R67-01,; ALINITY C ANALYZER, LIST 3R67-01,; SERIAL (B)(6); SERIAL (B)(6); SERIAL (B)(6); SERIAL (B)(6)
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