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

Catalog Number 03L80-31

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.

Event Description

The account stated the architect carbon dioxide (co2) is generating patient values 4 to 5 units lower than expected.An example was provided of architect co2 of 16 mmol/l but last month the patient was 24 mmol/l.The normal customer range is 22 to 31 mmol/l.No impact to patient management was reported.No specific patient information was provided.

Manufacturer Narrative

There are no atypical complaint trends for the carbon dioxide assay that require further investigation.Labeling is adequate and describes how co2 will decrease naturally when samples are exposed to air.The rate of co2 loss has been characterized and is present in labeling.A review of the customer's architect instrument logs shows the lower results, although several of the level 2 control results did fall below the expected range.When this occurs, the patient samples are flagged with a cntl result flag to notify the operator.Such flags are visible on the patient results reviewed.A review of the calibration data shows multiple calibrations in the month of (b)(6) and into (b)(6) 2018.In (b)(6), the calibrations show an increase in absorbance that indicates the calibrators are increasing in relative co2 concentration rather than decreasing as expected.This increase in the apparent concentration causes the calibration curve to depress further with each successive calibration, thus elevating the reported concentration of co2 in the qc and samples.The calibrators are susceptible to co2 loss just as patient samples and qc samples.The increase in absorbance change is clearly noted in the log review.However, the mechanism of the increase is not known.The customer recalibrated again in late october and the absorbance change was lower than previous calibrations; back to more typical values.The qc and patient values also returned to expected ranges and are higher as expected.This appears to be an isolated event with respect to the calibrators; possibly handling or contamination.No product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8087577
• MDR Text Key: 129184154
• Report Number: 1628664-2018-02025
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• 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
• Report Date: 03/04/2019

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: 05/31/2019
• Device Catalogue Number: 03L80-31
• Device Lot Number: 52780UQ04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 LIST 01G06-11; ARCHITECT C8000 LIST 01G06-11; SERIAL (B)(4). ; SERIAL (B)(4).