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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE
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ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE Back to Search Results
Model Number 07P7220
Device Problem High Readings (2459)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No patient information available.
 
Event Description
The customer generated falsely elevated alinity c carbon dioxide results for three patients in comparison to results generated on the architect platform.The following results were provided: patient 1 (sid not provided): initial 33 mmol/l, repeated on archtiect 29 mmol/l.Patient 2 (sid not provided): initial 31 mmol/l, repeated on archtiect 28 mmol/l.Patient 3 (sid not provided): initial 31 mmol/l, repeated on archtiect 28 mmol/l.The customer reported the architect results out of the lab.No impact to patient management was reported.
 
Manufacturer Narrative
D4 lot number has been identified as 58008uq08.A review of tickets determined that there is normal complaint activity for lot 58008uq08.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the carbon dioxide (co2) reagent (ln 7p72-20) lot 58008uq08 was identified.
 
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Brand Name
ALINITY C CARBON DIOXIDE REAGENT KIT
Type of Device
ENZYMATIC, CARBON-DIOXIDE
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key10896635
MDR Text Key241306454
Report Number3002809144-2020-01139
Device Sequence Number1
Product Code KHS
UDI-Device Identifier00380740121594
UDI-Public00380740121594
Combination Product (y/n)N
PMA/PMN Number
K060295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/26/2021
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 Date09/30/2021
Device Model Number07P7220
Device Catalogue Number07P72-20
Device Lot Number58008UQ08
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/12/2020
Initial Date FDA Received11/24/2020
Supplement Dates Manufacturer Received02/05/2021
Supplement Dates FDA Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALNTY C PROCESSING MODU, 03R67-01, AC01751; ALNTY C PROCESSING MODU, 03R67-01, AC01751
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