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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACON LABORATORIES, INC. MCKESSON CONSULT U120 URINE ANALYZER
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ACON LABORATORIES, INC. MCKESSON CONSULT U120 URINE ANALYZER Back to Search Results
Device Problem False Negative Result (1225)
Patient Problem Urinary Tract Infection (2120)
Event Type  malfunction  
Manufacturer Narrative
Acon complaint # (b)(4).
 
Event Description
The leukocyte parameter for the urinalysis strip is giving false negative results on the analyzer.When the samples are sent to a lab, the lab cultures indidicate a positive result for leukocytes.The strips were recently opened and were not expired.The strips are not discolored.They remove the strip tray every day to clean.They have run the controls and they pass.
 
Event Description
Customer returned the products in question for further testing.Review of manufacturing and qc records indicated that the products were manufactured without issue and met all the product release criteria.The returned strips and the retention sample of ther reported lot were tested with urine control solution and clinical samples.These were compared to siemens multistix.The restuls of both the returned product and the retention sample showed no anomalies.Although the returned strips showed a result of half a block difference, it was still within the acceptable criteria.Based on the batch record review and the product test results, the root cause could not be determined.No further investigation required as the frequency of occurrence of the complaint is improbable and the severity is negligible.We will continue to trend for similar complaints in the future.
 
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Brand Name
MCKESSON CONSULT U120 URINE ANALYZER
Type of Device
URINE ANALYZER
Manufacturer (Section D)
ACON LABORATORIES, INC.
5850 oberlin drive, #340
san diego, ca
MDR Report Key10329475
MDR Text Key200654905
Report Number2531491-2020-00007
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
PMA/PMN Number
K120124
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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