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

Catalog Number	03L80-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6289436
• Report Number: 1628664-2017-00019
• Device Sequence Number: 1564152
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 03L80-31
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C16000 SYSTEM, LIST # 03L77-01,; SERIAL #(B)(4)