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

Catalog Number	07D63-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer observed technopath qc shifting low out of range, when using the architect creatine kinase assay (list number 7d63, lot number 87697un18).No impact to patient management was reported.

• Brand Name: ARCHITECT CREATINE KINASE
• Common Device Name: CREATINE KINASE (CK)
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7988414
• Report Number: 1628664-2018-01959
• Device Sequence Number: 1311440
• Product Code: CGS
• UDI-Device Identifier: 00380740012878
• UDI-Public: 00380740012878
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K983070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2018
• Device Catalogue Number: 07D63-21
• Device Lot Number: 87697UN18
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1628664-07/19/18-002-R
• Patient Sequence Number: 1