ARCHITECT CREATINE KINASE 07D63-21

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-09-03 for ARCHITECT CREATINE KINASE 07D63-21 manufactured by Abbott Manufacturing Inc.

Event Text Entries

[119035326] A product recall letter was issued to all architect customers who have received architect creatine kinase, list number 07d63-21, lot number 99632un18. 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.
Patient Sequence No: 1, Text Type: N, H10


[119035327] The customer observed error code 1054 unable to calculate result, reaction check failure, for patient results when using the architect creatine kinase assay (list number 7d63, lot number 99632un18). No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1628664-2018-01758
MDR Report Key7840603
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-09-03
Date of Report2018-09-02
Date of Event2018-07-26
Date Mfgr Received2018-08-10
Device Manufacturer Date2018-03-28
Date Added to Maude2018-09-03
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 FDA3
Event Location3
Manufacturer ContactNOEMI ROMERO-KONDOS, RN BSN
Manufacturer Street100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224667-512
Manufacturer G1ABBOTT MANUFACTURING INC
Manufacturer Street1921 HURD DRIVE
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal Code75038
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number1628664-07/19/18-002-R
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT CREATINE KINASE
Generic NameCREATINE KINASE (CK)
Product CodeCGS
Date Received2018-09-03
Catalog Number07D63-21
Lot Number99632UN18
Device Expiration Date2018-11-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MANUFACTURING INC
Manufacturer Address1921 HURD DRIVE IRVING TX 75038 US 75038


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-03

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