MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number 03L80-31

Device Problem Low Test Results (2458)

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

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

This issue was previously reported under mdr number 1628664-2016-00298 under a different suspect device.The customer reported that some physicians are questioning low co2c results at one of their facilities.The customer did a study between different facilities and noticed the site with architect analyzer co2c results are 30% lower on all patients.The facility with (b)(4) analyzer showed only 5% lower result.A review of complaints found no trends or similar complaints identified for the list number.A review of nonconformances for the list number did not identify any issues related to this complaint.A review of the carbon dioxide reagent package insert and the architect system operations manual shows adequate labeling for the customer's issue is provided.Based on this investigation, neither a malfunction nor a deficiency was identified for the carbon dioxide reagent list number (b)(4).

Event Description

The customer stated that the architect analyzer is generating falsely decreased co2 results compared to their sister facility.The result example provided: sample from (b)(6) 2016 co2 =17 (range 20-29)/ redrawn on (b)(6) 2016 = 15 / physician questioned the result so patient was redrawn at sister site and the (b)(4) = 24 (range 21-31).There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• 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: 6289436
• MDR Text Key: 66149390
• Report Number: 1628664-2017-00019
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2017

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 Catalogue Number: 03L80-31
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 SYSTEM, LIST # 03L77-01,; SERIAL #(B)(4)