FDA.reportPublic FDA data

MAUDE MDR 8000559

MDR report key
8000559
Report number
1628664-2018-01970
Event key
0
Event type
3
Date of event
2018-07-27
Date received
2018-10-24
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 CREATINE KINASECREATINE KINASE (CK)ABBOTT MANUFACTURING INCCGS07D63-2187697UN18Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-240

Event Narratives#

N

Patient 1

A PRODUCT RECALL LETTER WAS ISSUED TO ALL ARCHITECT CUSTOMERS WHO HAVE RECEIVED ARCHITECT CREATINE KINASE, LIST NUMBER 07D63-21, LOT NUMBER 87697UN18. THE LETTER INFORMS THE CUSTOMER OF THE ISSUE REGARDING A STABILITY ISSUE THAT MAY LEAD TO QUALITY CONTROL RESULTS SHIFTING LOW OUT OF RANGE AND/OR ERROR CODE 1054 "UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE" FOR QUALITY CONTROL AND PATIENT SAMPLES. THE LETTER INSTRUCTS THE CUSTOMER TO DISCONTINUE USE OF THE SUSPECT LOTS AND DESTROY ANY REMAINING INVENTORY. THE CAUSE OF THE STABILITY FAILURE HAS BEEN TRACED TO A CONTAMINATION OF THE BULK MATERIAL.

D

Patient 1

THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR CONTROLS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.