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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY C CREATININE2; ALKALINE PICRATE, COLORIMETRY, CREATININE
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ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY C CREATININE2; ALKALINE PICRATE, COLORIMETRY, CREATININE Back to Search Results
Catalog Number 04T91-20
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2023
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
 
Event Description
The customer reported falsely elevated alinity c creatinine2 results for one 65-year-old female patient.The sample was repeated with lower results.The following data was provided: sample processed on (b)(6) 2023 sid (b)(6) initial creatinine2 result = 2.41 mg/dl repeat result (b)(6) 2023 on same sample which had been stored refrigerated = 0.83 mg/dl there was no impact to patient management reported.
 
Manufacturer Narrative
Upon further review, this mdr was inadvertently submitted.There is no similar product in the us therefore, no further information on this incident will be reported.
 
Event Description
The customer reported falsely elevated alinity c creatinine2 results for one 65-year-old female patient.The sample was repeated with lower results.The following data was provided: sample processed on (b)(6) 2023 sid (b)(6) initial creatinine2 result = 2.41 mg/dl repeat result (b)(6) 2023 on same sample which had been stored refrigerated = 0.83 mg/dl there was no impact to patient management reported.
 
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Brand Name
ALINITY C CREATININE2
Type of Device
ALKALINE PICRATE, COLORIMETRY, CREATININE
Manufacturer (Section D)
ABBOTT IRELAND DIAGNOSTICS DIVISION
lisnamuck
co. longford
longford N39E9 32
EI  N39E932
Manufacturer (Section G)
ABBOTT IRELAND DIAGNOSTICS DIVISION
lisnamuck
co. longford
longford N39E9 32
EI   N39E932
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18478694
MDR Text Key332729884
Report Number3005094123-2024-00016
Device Sequence Number1
Product Code CGX
Combination Product (y/n)N
Reporter Country CodeCS
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,Followup
Report Date 02/16/2024
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 Catalogue Number04T91-20
Device Lot Number51421UD00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/28/2023
Initial Date FDA Received01/09/2024
Supplement Dates Manufacturer Received02/16/2024
Supplement Dates FDA Received02/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2023
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, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
Patient Age65 YR
Patient SexFemale
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