FDA.reportPublic FDA data

MAUDE MDR 7899111

MDR report key
7899111
Report number
1628664-2018-01902
Event key
0
Event type
3
Date received
2018-09-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NOEMI ROMERO-KONDOS, RN BSN
Address
100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
Phone
224-224-2246
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARCHITECT ICT MODULEICT MODULEABBOTT MANUFACTURING INCCGZ09D28-03180326380Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-210

Event Narratives#

N

Patient 1

A PRODUCT RECALL LETTER WAS ISSUED TO ALL ARCHITECT CUSTOMERS WHO HAVE RECEIVED THE ARCHITECT ICT MODULE, LIST NUMBER 09D28-03, LOT NUMBER 180326 (180326301 THROUGH 180326399). THE LETTER INFORMS THE CUSTOMER OF THE ISSUE REGARDING HIGHER THAN EXPECTED SERUM OR PLASMA CHLORIDE RESULTS FOR QUALITY CONTROL AND PATIENT SAMPLES. THE LETTER INSTRUCTS THE CUSTOMER TO DISCONTINUE USE OF THE SUSPECT LOT AND DESTROY ANY REMAINING INVENTORY. THE CAUSE OF THE UPWARD SHIFT HAS BEEN TRACED TO AN OMITTED PROCESS STEP DURING THE MANUFACTURE OF THE CHLORIDE ELECTRODE ELEMENT OF THE ICT MODULE.

D

Patient 1

THE CUSTOMER REPORTED CHLORIDE CONTROLS SHIFTED HIGH OUT OF RANGE WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326380). NO DISCREPANT PATIENT RESULTS WERE GENERATED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.