MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CO2-L; ENZYMATIC, CARBON-DIOXIDE

Catalog Number	08057494190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only one sample for this patient is affected.The customer is not having issues with other patient samples tested for co2-l.The sample was requested for investigation.H3 other text: na.
Event or Problem Description
The initial reporter questioned the results of 1 patient sample tested for bicarbonate liquid (co2-l) on a c503 instrument.The initial result was 2.59 mmol/l.An additional result of < 2 mmol/l was also provided.A ½ dilution was performed and the result was 4.73 mmol/l.An additional result of 4 mmol/l was also provided.The sample was tested on a different c503 instrument and the same results were obtained.The specific results were not provided.A second sample was obtained from the patient and the same results were obtained.The specific results were not provided.The sample was tested on a radiometer abl800 flex blood gas instrument with elevated results.The pco2 results from the blood gas instrument from the plasma sample were 20.0 mmhg and 23.9 mmhg.The pco2 results from the blood gas instrument using a whole blood sample were 20.4 mmhg and 19.3 mmhg.Additional samples were obtained from the patient and tested on different c503 instruments.See attached data for the results.A lipogram was performed and the results suggest a higher level of chylomycron in the sample.The customer suspects an interference affecting the results.The c503 instrument serial number was not provided.
Additional Manufacturer Narrative
The initial report stated: "the sample was tested on a different c503 instrument and the same results were obtained.The specific results were not provided.A second sample was obtained from the patient and the same results were obtained.The specific results were not provided." the following additional co2 results were provided that were performed on (b)(6)2023: 1.92 mmol/l with a data flag.9.57 mmol/l 4.34 mmol/l 4.77 mmol/l [-] 0.0229 mmol/l 1.93 mmol/l 1.90 mmol/l the investigation is ongoing.
Additional Manufacturer Narrative
The c503 instrument serial number was (b)(6).Section a2 was updated.Section b7 was updated.
Additional Manufacturer Narrative
Calibration data was acceptable.The alarm trace data from the day of the event was not provided.Abnormal aspiration alarms and sample foam alarms were observed on the alarm trace data provided.Based on the information provided, the specific cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: CO2-L
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17040412
• Report Number: 1823260-2023-01806
• Device Sequence Number: 7012243
• Product Code: KHS
• UDI-Device Identifier: 07613336121146
• UDI-Public: 07613336121146
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K031879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/27/2023

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 Catalogue Number: 08057494190
• Device Lot Number: 657730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 09/15/2023; 12/27/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/24/2023; 10/25/2023; 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Unknown