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

Catalog Number 03289923190

Device Problem Low Test Results (2458)

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

Event Date 09/27/2023

Event Type  malfunction  

Event 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).

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.

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
• Type of Device: 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
• MDR Text Key: 328825593
• Report Number: 1823260-2023-03753
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 04015630919352
• UDI-Public: 04015630919352
• Combination Product (y/n): Y
• PMA/PMN Number: K031879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 03289923190
• Device Lot Number: 71047401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BISOPROLOL; COUMADIN; FUROSEMIDE; LEVOTHYROX; MACROFOL; SERESTA; TRIMEBUTIN; ZOPICLONE
• Patient Age: 91 YR
• Patient Sex: Female