SYSMEX UF-1000I *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-06 for SYSMEX UF-1000I * manufactured by Sysmex America, Inc..

Event Text Entries

[4131114] Patient presented to the emergency department with abdominal pain, vomiting, and fever. The attending physician ordered a urinalysis to confirm a diagnosis of a urinary tract infection. The laboratory technician performing the test accidentally caused the report to include a false positive showing the presence of spermatozoa. The device in question is meant to flag the presence of spermatozoa, though the flag is not meant to be definitive. The flag merely indicates that there is something in the test on the flow that the spermatozoa would usually appear, such as mucus or yeast cells. The flag is meant to alert the technician to the potential presence of spermatozoa in order for a more accurate verification to occur. In this particular case, the technician missed the flag indicating a potentially positive result, and the presence of spermatozoa was reported on the laboratory results for this patient. Because the patient was a young minor, our facility's child sexual abuse protocol triggered. The local police and child protective services were contacted and reported to our facility. The patient was transferred to another facility for higher level of care, given the diagnosis of suspected sexual abuse of a child. The results was later shown to be a false positive.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3621990
MDR Report Key3621990
Date Received2014-02-06
Date of Report2014-02-06
Date of Event2014-02-04
Report Date2014-02-06
Date Reported to FDA2014-02-06
Date Reported to Mfgr2014-02-11
Date Added to Maude2014-02-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSYSMEX UF-1000I
Generic NameCOUNTER, URINE PARTICLE
Product CodeLKM
Date Received2014-02-06
Model NumberUF-1000I
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device Sequence No1
Device Event Key0
ManufacturerSYSMEX AMERICA, INC.
Manufacturer AddressONE NELSON C. WHITE PARKWAY MUNDELEIN IL 60060 US 60060


Patients

Patient NumberTreatmentOutcomeDate
10 2014-02-06

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