MAUDE Adverse Event Report: ABBOTT LABORATORIES CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number 03L80-21

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

This issue was previously reported under mdr number 1628664-2015-00337 under a different suspect device.(b)(4).A followup report will be submitted when the evaluation is complete.Evaluation in process.

Event Description

The account stated 2 patient samples generated elevated architect co2 results when processing on the pm shift that were repeated on the am shift with lower values.Id (b)(6) (female, date of birth of 1986) generated elevated architect co2 of 31.5 meq/l but repeated 23.3 meq/l.Id (b)(6) (female, date of birth of 1974) generated elevated architect co2 of 31.9 meq/l but repeated 23.5 meq/l.The account uses a reference range of 22 to 29 meq/l (19 to 59 years old) and 23 to 31 meq/l (60 years old and above).No impact to patient management was reported.

Manufacturer Narrative

The field service representative replaced several instrument parts for troubleshooting; however, replacing those parts did not resolve the customer's issue.Product information, pi03sep2013 provides information regarding the restandardization and updated storage conditions for abbott carbon dioxide calibrator.It states both that co2 results may shift on average of 4 to 8 percent and the restandardization provides closer alignment to the reported all method mean survey data provided by the college of american pathologists.It also lists revised storage conditions of 2 to 8 degrees celsius.The co2 calibrator package insert provides information on the standardization and limitations of the co2 assay.The architect system operations manual, provides guidance for assay results in regards to symptoms, other test results, clinical impressions and other diagnostic procedures that must be considered for patient care management.Additional information was provided during the evaluation that the customer's co2 issues were due to their external water source not having the ability to keep up with sample demand of their c4000 analyzer.Based on available information and the results of this investigation, carbon dioxide reagent lot 47946uq07 is performing acceptably.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• 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: 5431310
• MDR Text Key: 38706489
• Report Number: 1415939-2016-00024
• Device Sequence Number: 1
• Product Code: KHS
• 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: 03/10/2016

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: 08/31/2016
• Device Catalogue Number: 03L80-21
• Device Lot Number: 47946UQ07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• 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