ICHEM VELOCITY CONTROL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-11 for ICHEM VELOCITY CONTROL manufactured by Iris International.

Event Text Entries

[3991239] Customer getting discordant results with 20 patients between ichem velocity (negative) and iq200 (positive). Customer reported that one patient sample was negative on chemistry and had >45 rbc's. The other 19 patient samples were also negative on chemistry and had approximately 5 rbc's. The presence of rbc's was confirmed with manual microscope in all patients.
Patient Sequence No: 1, Text Type: D, B5


[11657704] 2023446-2013-00034. Iris product ifu insert states that the diagnostic or therapeutic decisions should not be based on any single result or method. No reports of change in patient management or injuries were reported. The following mdrs are related to this event. 2023446-2013-0024, -00025, -00026, -00027, -00028, -00029, -00030, -00031, -00032, -00033, -0034, -00035, -00036, -00037, -00038, -00039, -00040, -00041, -00042.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2023446-2013-00034
MDR Report Key3636136
Report Source05
Date Received2013-12-11
Date of Report2013-12-11
Date of Event2013-08-31
Date Mfgr Received2013-08-31
Device Manufacturer Date2013-08-01
Date Added to Maude2014-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSUDHA GUPTA
Manufacturer Street9172 ETON AVE.
Manufacturer CityCHATSWORTH CA 91311
Manufacturer CountryUS
Manufacturer Postal91311
Manufacturer Phone8185277497
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameICHEM VELOCITY CONTROL
Generic NameICHEM VELOCITY CONTROL
Product CodeJJW
Date Received2013-12-11
Lot Number213-13
ID Number800-7704, 800-7217
Device Expiration Date2014-07-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerIRIS INTERNATIONAL
Manufacturer AddressCHATSWORTH CA 91311 US 91311


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-12-11

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