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

Catalog Number 03L80-21

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

This issue was previously reported under mdr number 1415939-2018-00108 for the incorrect manufacturer: abbott laboratories, (b)(4), usa.This submission corrects the manufacturer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a.Patient information, 1.Patient identifier: multiple = sid (b)(6).There is no further patient information obtained from the customer.

Event Description

The customer reported falsely elevated co2 results on multiple patients.The results provided were for 5 samples: sid (b)(6) = 33.27 / 24.67; sid (b)(6) = 31.89 / 24.26; sid (b)(6) = 31.75 / 23.68; sid (b)(6) = 32.47 / 24.67; sid (b)(6) = 32.87 / 24.52.There was no reported impact to patient management.

Manufacturer Narrative

A review of the architect serial number (b)(4) instrument logs was performed.The sample identification data and co2 results were located and the initial results were generated around 12:54 / first rerun at 14:09 / second rerun at 14:27 hours / and the third rerun at 15:27.A larger drop in co2 results occurred between the initial testing and the follow up testing which was approximately 1 hour 20 minutes between measurements.A review of tickets for lot 51686uq08 identified one other complaint which was also for patient results, however, the investigation found no deficiency.There were no trends identified for this lot for similar issues.A review of labeling was found to adequately address the issue.Samples, on average, may lose up to 6% of their total co2 within the first hour.Additional environmental conditions such as drafts from air conditioning or air handling systems (fans, etc), sample handling or storage after the initial analysis may increase the speed of sample co2 loss.Based on the investigation no product deficiency was identified for the clin chem co2 reagent, lot 51686uq08.

Manufacturer Narrative

Correction to suspect medical device.Manufacturer from: abbott laboratories 100 abbott park road abbott park, il 60064-3500, usa mail to:(b)(4).Fax: (b)(4).To: abbott manufacturing inc 1921 hurd drive, irving, tx 75038, usa; correction to all manufacturers, manufacturing site for devices: from abbott laboratories, 100 abbott park road, abbott park, il 60064-3500, usa mail to:(b)(4).Fax: (b)(4).To: abbott manufacturing inc 1921 hurd drive, irving, tx 75038, usa.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038 3500
• MDR Report Key: 7671710
• MDR Text Key: 113515161
• Report Number: 1628664-2018-00265
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (y/n): N
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2018

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: 09/30/2018
• Device Catalogue Number: 03L80-21
• Device Lot Number: 51686UQ08
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 08/17/2018; 08/17/2018
• Supplement Dates FDA Received: 09/05/2018; 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER, LIST # 02P24-01; ARCHITECT C4000 ANALYZER, LIST # 02P24-01; ARCHITECT C4000 ANALYZER, LIST # 02P24-01; SERIAL # (B)(4). ; SERIAL # (B)(4). ; SERIAL # (B)(4).