FDA.reportPublic FDA data

MAUDE MDR 3636148

MDR report key
3636148
Report number
2023446-2013-00024
Event key
0
Event type
3
Date of event
2013-08-31
Date received
2013-12-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
SUDHA GUPTA
Address
9172 ETON AVE. CHATSWORTH CA 91311 US
Phone
818-818-8185
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ICHEM VELOCITY CONTROLICHEM VELOCITY CONTROLIRIS INTERNATIONALJJW213-13R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-12-1101. O

Event Narratives#

D

Patient 1

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.

N

Patient 1

(B)(4). 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.