MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Model Number 07P7220

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated carbon dioxide (co2) results on alinity c processing module for several patients on multiple analyzers.Some of the results reported out of the laboratory and need to repeat and correct those co2 results.The co2 results from line 1 and 2 provided were: the unit of measure is mmol/l on (b)(6) 2023 line 1: sid (b)(6) initial=35 /repeated=29.Line 2: sid (b)(6) initial=35 /repeated=28.Sid (b)(6) initial=34 /repeated=28.Sid (b)(6) initial=33 /repeated=27.Additional information provided: sid (b)(6) initial=29.9 /repeated=26.3.Sid (b)(6) initial=30.1 /repeated=25.9.Sid (b)(6), initial=32.9 /repeated=28.2.Sid (b)(6) initial=30.5 /repeated=25.4 sid (b)(6), ,initial=33.2 /repeated=28.2.Sid (b)(6) initial=32.8 /repeated=26.8.Sid (b)(6), initial=31.8 /repeated=26.3.Sid (b)(6) initial=31.7 /repeated=26.5.Sid (b)(6), initial=30.2 /repeated=27.5.Sid (b)(6) initial=30.0 /repeated=26.2.Sid (b)(6), initial=31.9 /repeated=28.3.Sid (b)(6) initial=31.6 /repeated=28.8.Sid (b)(6), initial=31.4 /repeated=26.7.Sid (b)(6) initial=30.5 /repeated=27.3.Sid (b)(6), initial=29.4 /repeated=26.4.Sid (b)(6) initial=29.3 /repeated=24.4.Sid (b)(6), initial=30.1 /repeated=27.7.Sid (b)(6) initial=33.1 /repeated=28.5.Sid (b)(6), initial=32.7 /repeated=28.6.Sid (b)(6) initial=29.3 /repeated=25.8.Sid (b)(6), initial=30.2 /repeated=27.1.Sid (b)(6) initial=35.1 /repeated=28.8.Sid (b)(6), initial=32.9 /repeated=25.8.Sid (b)(6) initial=32.4 /repeated=26.2.Sid (b)(6), initial=32.8 /repeated=25.7.Sid (b)(6) initial=30.4 /repeated=23.7.Sid (b)(6), initial=30.6 /repeated=23.8.Sid (b)(6) initial=29.3 /repeated=22.9.Sid (b)(6), initial=32.8 /repeated=26.7.Sid (b)(6) initial=32.8 /repeated=28.7.Sid (b)(6), initial=31.9 /repeated=28.6.Sid (b)(6) initial=32.6 /repeated=27.1.Sid (b)(6), initial=30.0 /repeated=25.1.Sid (b)(6) initial=30.5 /repeated=25.2.Sid (b)(6), initial=31.1 /repeated=27.0.Sid (b)(6) initial=30.8 /repeated=24.8.Sid (b)(6), initial=31.4 /repeated=28.5.Sid (b)(6) initial=31.7 /repeated=28.8.Sid (b)(6), initial=30.9 /repeated=28.2.Sid (b)(6) initial=30.4 /repeated=28.3.Sid (b)(6), initial=29.4 /repeated=27.5.Sid (b)(6) initial=30.8 /repeated=27.9.Sid (b)(6), initial=30.4 /repeated=28.5.Laboratory reference range for carbon dioxide=20 to 30 mmol/l.Note: results expressed in mmol/l are equivalent to meq/l for this analyte.There was no reported impact to patient management.

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier = sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated carbon dioxide (co2) results on alinity c processing module for several patients on multiple analyzers.Some of the results reported out of the laboratory and need to repeat and correct those co2 results.The co2 results from line 1 and 2 provided were: the unit of measure is mmol/l on (b)(6) 2023 line 1: sid (b)(6) initial=35 /repeated=29 line 2: sid (b)(6) initial=35 /repeated=28; sid (b)(6) initial=34 /repeated=28; sid (b)(6) initial=33 /repeated=27; additional information provided: sid (b)(6) initial=29.9 /repeated=26.3; sid (b)(6) initial=30.1 /repeated=25.9; sid (b)(6) initial=32.9 /repeated=28.2; sid (b)(6) initial=30.5 /repeated=25.4; sid (b)(6) initial=33.2 /repeated=28.2; sid (b)(6) initial=32.8 /repeated=26.8; sid (b)(6) initial=31.8 /repeated=26.3; sid (b)(6) initial=31.7 /repeated=26.5; sid (b)(6) initial=30.2 /repeated=27.5; sid (b)(6) initial=30.0 /repeated=26.2; sid (b)(6) initial=31.9 /repeated=28.3; sid (b)(6) initial=31.6 /repeated=28.8; sid (b)(6) initial=31.4 /repeated=26.7; sid (b)(6) initial=30.5 /repeated=27.3; sid (b)(6) initial=29.4 /repeated=26.4; sid (b)(6) initial=29.3 /repeated=24.4; sid (b)(6) initial=30.1 /repeated=27.7; sid (b)(6) initial=33.1 /repeated=28.5; sid (b)(6) initial=32.7 /repeated=28.6; sid (b)(6) initial=29.3 /repeated=25.8; sid (b)(6) initial=30.2 /repeated=27.1; sid (b)(6) initial=35.1 /repeated=28.8; sid (b)(6) initial=32.9 /repeated=25.8; sid (b)(6) initial=32.4 /repeated=26.2; sid (b)(6) initial=32.8 /repeated=25.7; sid (b)(6) initial=30.4 /repeated=23.7; sid (b)(6) initial=30.6 /repeated=23.8; sid (b)(6) initial=29.3 /repeated=22.9; sid (b)(6) initial=32.8 /repeated=26.7; sid (b)(6) initial=32.8 /repeated=28.7; sid (b)(6) initial=31.9 /repeated=28.6; sid (b)(6) initial=32.6 /repeated=27.1; sid (b)(6) initial=30.0 /repeated=25.1; sid (b)(6) initial=30.5 /repeated=25.2; sid (b)(6) initial=31.1 /repeated=27.0; sid (b)(6) initial=30.8 /repeated=24.8; sid (b)(6) initial=31.4 /repeated=28.5; sid (b)(6) initial=31.7 /repeated=28.8; sid (b)(6) initial=30.9 /repeated=28.2; sid (b)(6) initial=30.4 /repeated=28.3; sid (b)(6) initial=29.4 /repeated=27.5; sid (b)(6) initial=30.8 /repeated=27.9; sid (b)(6) initial=30.4 /repeated=28.5; laboratory reference range for carbon dioxide=20 to 30 mmol/l note: results expressed in mmol/l are equivalent to meq/l for this analyte.There was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review for alinity carbon dioxide reagent lot number 62643uq08 and alinity co2 calibrator lot 93689fd01.The ticket search determined that there is as expected complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.The issue description stated when the patient results are observed to be elevated, qc is retested and are also elevated.The reagent is replaced with a new cartridge and calibrated and then qc is back in range.Labeling states abnormally elevated or fluctuating co2 levels in the laboratory may interfere with carbon dioxide measurements, leading to inaccurate results.Under these circumstances, more frequent calibrations may be necessary.Labeling states a control value is out of the specified range.Associated test results are invalid, and samples must be retested.Assay recalibration may be necessary.The customer followed this direction, and the qc was back in range.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity carbon dioxide reagent , lot 62643uq08 and alinity co2 calibrator lot 93689fd01 were identified.

• Brand Name: ALINITY C CARBON DIOXIDE REAGENT KIT
• Type of Device: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16911521
• MDR Text Key: 315003897
• Report Number: 3002809144-2023-00230
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: 00380740121594
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 07P7220
• Device Catalogue Number: 07P72-20
• Device Lot Number: 62643UQ08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C CARBON DIOXID, 08P72-01, 93689FD01; ALNTY C PROCESSING MODU, 03R67-01, AC03650; ALNTY C PROCESSING MODU, 03R67-01, AC03650