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 Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.
Event or Problem 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.
Additional 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
• Common Device Name: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8087577
• Report Number: 1628664-2018-02025
• Device Sequence Number: 1734531
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 03/04/2019
• 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 C8000 LIST 01G06-11; ARCHITECT C8000 LIST 01G06-11; SERIAL (B)(4). ; SERIAL (B)(4).