MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT CREATINE KINASE; CREATINE KINASE (CK)

Catalog Number 07D63-21

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer observed error code 1054 unable to calculate result, reaction check failure, for low technopath control and patient results when using the architect creatine kinase assay (list number 7d63, lot number 99632un18).No impact to patient management was reported.

• Brand Name: ARCHITECT CREATINE KINASE
• Type of Device: CREATINE KINASE (CK)
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 7837568
• MDR Text Key: 118923026
• Report Number: 1628664-2018-01723
• Device Sequence Number: 1
• Product Code: CGS
• UDI-Device Identifier: 00380740012878
• UDI-Public: 00380740012878
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K983070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2018
• Device Catalogue Number: 07D63-21
• Device Lot Number: 99632UN18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1628664-07/19/18-002-R
• Patient Sequence Number: 1
• Treatment: (B)(4); ARCHITECT C16000, LIST 03L77,