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 Patient Involvement (2645)

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 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.

Event Description

The customer reported they received the letter associated with qc shifting low and error code 1054 unable to calculate result, reaction check failure for the architect creatine kinase assay (list number 7d63, lot number 87697un18).No further information could be obtained and no impact to patient management was reported.

Manufacturer Narrative

Upon further review, the customer's issue is not associated with remedial action 1628664-07/19/18-002-r and is unassigned from the field action.

• Brand Name: ARCHITECT CREATINE KINASE
• Type of Device: CREATINE KINASE (CK)
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8279002
• MDR Text Key: 134195540
• Report Number: 1628664-2019-00057
• Device Sequence Number: 1
• Product Code: CGS
• UDI-Device Identifier: 00380740012878
• UDI-Public: 00380740012878
• Combination Product (y/n): N
• PMA/PMN Number: K983070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2018
• Device Catalogue Number: 07D63-21
• Device Lot Number: 87697UN18
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1628664-07/19/18-002-R
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000, LIST 02P24,; ARCHITECT C4000, LIST 02P24,; SERIAL (B)(4). ; SERIAL (B)(4).