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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  
Event Description
The leukocyte and blood paramters for the urinalysis strips is giving false negative results on the analyzer compared to the lab results.The strips were open for less than a week and are not expired.Instructions are being followed and analyzer is routinely being cleaned.Patient was symptomatic for uti.
 
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 analyzer was returned for further investigation.Clinical samples were tested with the mckesson strips, siemens analyzer and siemens strips and the retention strips from the customer.The results of both the returned product and the retention sample showed no anomalies and the false negative results could not be reproduced.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,
MDR Report Key10333746
MDR Text Key200655396
Report Number2531491-2020-00008
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 distributor
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Date Manufacturer Received07/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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