MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT ICT MODULE

Catalog Number 09D28-03

Device Problem High Test Results (2457)

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

Event Date 11/13/2018

Event Type  malfunction  

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 Description

The customer observed multiple falsely elevated chloride (cl) results and anion gap out of range while using the architect c8000 analyzer ict module.The following data was provided for one patient.The customer uses chloride normal range 98 to 107 mmol/l.Per the ict diluent product package insert, anion gap values are calculated as sodium (na) minus the sum of carbon dioxide (co2) and chloride (cl).Patient 1 initial 144 mmol/l, repeat using another analyzer 106 mmol/l, repeat using the same analyzer after cleaning 113 mmol/l.Patient 2 (sid (b)(6)) initial 114 mmol/l, repeat using another analyzer 106 mmol/l.No impact to patient management was reported.

• Brand Name: ARCHITECT ICT MODULE
• Type of Device: ICT MODULE
• 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: 8135214
• MDR Text Key: 130190478
• Report Number: 1628664-2018-02112
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 00380740019327
• UDI-Public: 00380740019327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2018
• Device Catalogue Number: 09D28-03
• Device Lot Number: 180326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1628664-08/29/18-003-R
• Patient Sequence Number: 1