MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT ICT MODULE

Catalog Number	09D28-03
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product recall letter was issued to all architect customers who have received the architect ict module, list number 09d28-03, lot number 180326.The letter informs the customer of the issue regarding higher than expected serum or plasma chloride results for quality control and patient samples.The letter instructs the customer to discontinue use of the suspect lot and destroy any remaining inventory.The cause of the upward shift has been traced to an omitted process step during the manufacture of the chloride electrode element of the ict module.
Event or Problem Description
Abbott laboratories has confirmed higher than expected serum or plasma chloride results when using architect ict module, ln 09d28-03, lot number 180326.Based on an analysis of qc data from existing customers, the results generated using this lot number may be up to 6.2% higher than expected.This qc analysis does not indicate an issue with urine chloride results.Additionally, since this issue only impacts the chloride electrode element of the ict module, potassium and sodium results are not impacted.There has been no report of impact to patient management due to this issue.However, there is a potential to generate falsely elevated serum or plasma chloride results.There is also the potential to delay the reporting of chloride ict results due to the time required for the user to attempt troubleshooting of the issue with falsely elevated serum chloride quality control results.

• Brand Name: ARCHITECT ICT MODULE
• Common Device Name: ICT MODULE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7830570
• Report Number: 1628664-2018-01620
• Device Sequence Number: 16755884
• Product Code: CGZ
• UDI-Device Identifier: 00380740019327
• UDI-Public: 00380740019327
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K980367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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: 12/26/2018
• Device Catalogue Number: 09D28-03
• Device Lot Number: 180326
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/29/2018
• 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: 1628664-08/29/18-003-R
• Patient Sequence Number: 1