ICHEM 100 800-7005

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 2013-11-22 for ICHEM 100 800-7005 manufactured by Iris International.

Event Text Entries

[4464724] False positive leukocyte esterase was reported on 101 pt results which lead to 12 pts to receive unnecessary antibiotics. The malfunction was confirmed by urine microscopy and urine cultures which were negative for urinary tract infection in all 12 pts.
Patient Sequence No: 1, Text Type: D, B5


[11795132] Iris product ifu insert states that the diagnostic or therapeutic decisions should not be based on any single result or method. Therefore decision of clinician to administer therapy based on single false positive or false negative result is indicative of uses of device off labeled claim. The following mdrs are related to this event: 2023446-2013-00001, 2023446-2013-0003, 0004, 0005, 0006, 0007, 0008, 0009, 0010, 0011, 0012, 0013.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2023446-2013-00010
MDR Report Key3748620
Report Source05
Date Received2013-11-22
Date of Report2013-11-22
Date of Event2013-08-15
Date Mfgr Received2013-08-15
Device Manufacturer Date2013-04-01
Date Added to Maude2014-05-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional0
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 Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameICHEM 100
Generic NameURINE CHMISTRY STRIPS
Product CodeJJW
Date Received2013-11-22
Model Number800-7005
Lot Number51000
Device Expiration Date2015-04-01
OperatorHEALTH PROFESSIONAL
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 2013-11-22

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