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

Catalog Number	03289923190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for four samples from the same patient tested with co2-l (bicarbonate) on a cobas 8000 cobas c 502 module.The results obtained for the patient did not fit the patient's diagnosis of acidosis.The first sample resulted in a bicarbonate value of 4 mmol/l on (b)(6) 2023.The second sample resulted in a bicarbonate value of 4 mmol/l on (b)(6) 2023.The third sample resulted in a bicarbonate value of 4 mmol/l on (b)(6) 2023.The fourth sample resulted in a bicarbonate value of 6.1 mmol/l on (b)(6) 2023.On an unknown date, a sample from the patient was tested on an unknown blood gas analyzer, resulting in the following values: ph = 7.35, paco2 = 49 (no units provided), pao2 = 88 (no units provided), bicarbonate = 26 mmol/l, lactate = 2.1 (no units provided).
Additional Manufacturer Narrative
The serial number of the c 502 module is (b)(6).The last calibration performed on 18-oct-2023 was ok.Quality controls recovered within range.A general reagent issue can be ruled out as calibration and controls are acceptable.
Additional Manufacturer Narrative
Protein electrophoresis was performed on a sample from the patient and a peak in the gamma globulin fraction was identified.Gammopathy of the patient cannot be excluded.A general reagent issue can be ruled out as calibration and controls are acceptable.The investigation determined that the issue is consistent with monoclonal gammopathy of the patient.The investigation could not identify a product problem.Per product labeling: "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.".

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18194372
• Report Number: 1823260-2023-03753
• Device Sequence Number: 6439771
• Product Code: KHS
• UDI-Device Identifier: 04015630919352
• UDI-Public: 04015630919352
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 01/12/2024

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: 10/31/2024
• Device Catalogue Number: 03289923190
• Device Lot Number: 71047401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BISOPROLOL; COUMADIN; FUROSEMIDE; LEVOTHYROX; MACROFOL; SERESTA; TRIMEBUTIN; ZOPICLONE
• Patient Sex: Female