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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C16000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
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ABBOTT LABORATORIES ARCHITECT C16000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Back to Search Results
Catalog Number 03L77-01
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2024
Event Type  malfunction  
Event Description
The customer observed falsely decreased sodium results generated on the architect c16000 processing module for 5 samples.The samples were repeated, and higher results were obtained.The following data was provided: patient 1 on (b)(6) 2024 sodium initial result = 117.6 mmol/l; repeat result = 141.6 mmol/l.Patient 2 on (b)(6) 2024 sodium initial result = 113 mmol/l; repeat result = 139 mmol/l.Patient 3 on (b)(6) 2024 sodium initial result = 113.6 mmol/l; repeat result = 140 mmol/l.Patient 4 on (b)(6) 2024 sodium initial result = 119 mmol/l; repeat result = 141 mmol/l.Patient 5 on (b)(6) 2024 sodium initial result = 120 mmol/l; repeat result = 139 mmol/l.Approximate reference (normal) range: 136 to 145 mmol/l.There was no impact to patient management reported.
 
Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
Update b5- new patient information: on (b)(6) 2024, the customer provided another falsely decreased sodium result for one patient while running on the architect c16000 processing module.The initial result was 120 mmol/l and the repeat result was 140 mmol/l.Update: d4 - primary udi number initial: (b)(4) / updated to ((b)(4).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 observed falsely decreased sodium results generated on the architect c16000 processing module for 5 samples.The samples were repeated, and higher results were obtained.The following data was provided: patient 1: (b)(6) 2024 sodium initial result = 117.6 mmol/l; repeat result = 141.6 mmol/l.Patient 2: (b)(6) 2024 sodium initial result = 113 mmol/l; repeat result = 139 mmol/l.Patient 3: (b)(6) 2024 sodium initial result = 113.6 mmol/l; repeat result = 140 mmol/l.Patient 4: (b)(6) 2024 sodium initial result = 119 mmol/l; repeat result = 141 mmol/l.Patient 5: (b)(6) 2024 sodium initial result = 120 mmol/l; repeat result = 139 mmol/l.Update: on (b)(6) 2024, the customer provided another falsely decreased sodium result for one patient while running on the architect c16000 processing module.The initial result was 120 mmol/l and the repeat result was 140 mmol/l.Approximate reference (normal) range: 136 to 145 mmol/l.
 
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Brand Name
ARCHITECT C16000
Type of Device
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Manufacturer (Section D)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer (Section G)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18950693
MDR Text Key338314066
Report Number3016438761-2024-00170
Device Sequence Number1
Product Code JJE
UDI-Device Identifier00380740005924
UDI-Public(01)00380740005924(21)C1600663
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
EXEMPT
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 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03L77-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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