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 Known Impact Or Consequence To Patient (2692)
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 (180326301 through 180326399).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
The account observed falsely depressed architect chloride results causing negative anion gaps for patient samples.The issue occurred while using the architect ict module (list number 9d28-03, lot number 180326343 on the architect c8000.The result log showed chloride results ranging from 105 to 110 mmol/l.The ict module was replaced for resolution.No impact to patient management was reported.

• 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: 7899313
• Report Number: 1628664-2018-01905
• Device Sequence Number: 1706837
• Product Code: CGZ
• UDI-Device Identifier: 00380740019327
• UDI-Public: 00380740019327
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: 12/26/2018
• Device Catalogue Number: 09D28-03
• Device Lot Number: 180326343
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 09/21/2018
• 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: 1628664-08/29/18-003-R
• Patient Sequence Number: 1