MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 6 SYSTEM; BLOOD GAS ANALYZER

Catalog Number	03337154001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ise indirect na, k for gen.2 and ca calcium results from samples from two patients tested on the cobas b 221 6 roche omni s6 system.Sample 1 on (b)(6) 2023: the initial k result at 11:23 am was an error message.The first repeat k result at 11:25 am was 10.88 mmol/l.The second repeat k result at 11:32 am was 3.90 mmol/l.The initial na result at 11:23 am was an error message.The first repeat na result at 11:25 am was 134.8 mmol/l.The second repeat na result at 11:32 am was 141.4 mmol/l.The initial ca result at 11:23 am was an error message.The first repeat ca result at 11:25 am was 0.859 mmol/l.The second repeat ca result at 11:32 am was 1.192 mmol/l.Sample 2 on (b)(6) 2023 at 11:52 pm, the initial k result was 8.52 mmol/l.On (b)(6) 2023 at 12:00 am, the first repeat k result was an error message.The second repeat k result at 12:07 am was 4.23 mmol/l.
Additional Manufacturer Narrative
The cartridge lot numbers and the expiration dates were requested but not provided.The investigation is ongoing.
Additional Manufacturer Narrative
In mfg report no 1823260-2023-03243, b5 describe event or problem should have been: "the initial reporter received questionable ise indirect na, k for gen.2 and ca calcium results from samples from two patients tested on the cobas b 221 6 roche omni s6 system.Sample 1 on (b)(6) 2023: at 11:29 am, the k result was 4.14 mmol/l; the na result was 141.5 mmol/l; and the ca result was 1.178 mmol/l.On (b)(6) 2023: at 6:16 am, there were no k, na and ca results as the ion-selective electrode parameters were not calibrated.At 11:23 am, the result was an error message.At 11:25 am, the k result was 10.88 mmol/l; the na result was 134.8 mmol/l; and the ca result was 0.859 mmol/l.At 11:32 am, the k result was 3.9 mmol/l; the na result was 141.4 mmol/l; and the ca result was 1.192 mmol/l.At 4:24 pm, the k result was 3.52 mmol/l; the na result was 143.7 mmol/l; and the ca result was 1.214 mmol/l.Sample 2 on (b)(6) 2023: at 6:24 pm, the k result was 4.33 mmol/l.On (b)(6) 2023: at 11:52 pm, the k result was 8.52 mmol/l.On (b)(6) 2023: at 12:00 am, the result was an error message.At 12:07 am, the k result was 4.23 mmol/l.At 4:41 am, the k result was 4.02 mmol/l." instead of: "the initial reporter received questionable ise indirect na, k for gen.2 and ca calcium results from samples from two patients tested on the cobas b 221 6 roche omni s6 system.Sample 1 on (b)(6) 2023: the initial k result at 11:23 am was an error message.The first repeat k result at 11:25 am was 10.88 mmol/l.The second repeat k result at 11:32 am was 3.90 mmol/l.The initial na result at 11:23 am was an error message.The first repeat na result at 11:25 am was 134.8 mmol/l.The second repeat na result at 11:32 am was 141.4 mmol/l.The initial ca result at 11:23 am was an error message.The first repeat ca result at 11:25 am was 0.859 mmol/l.The second repeat ca result at 11:32 am was 1.192 mmol/l.Sample 2 on (b)(6) 2023 at 11:52 pm, the initial k result was 8.52 mmol/l.On (b)(6) 2023 at 12:00 am, the first repeat k result was an error message.The second repeat k result at 12:07 am was 4.23 mmol/l." the investigation requested the electrodes and spare parts used in the analyzer but they were not received for investigation.The investigation reviewed the measurement printouts.The investigation noted that for sample 1, the results at 11:23 am and 11:32 am were from the same blood collection from different sample tubes.The investigation noted that the high k results combined with the low ca results are consistent with the effects of hemolysis and that the error message received was consistent with a sample-related issue.The investigation noted that for sample 2, the results at 11:52 pm and 12:07 am were from the same blood collection from different sample tubes.The investigation noted that the high k results were from a hemolyzed sample as they correlated with the na and ca results provided; and that the error message received was consistent with a sample-related issue.The investigation reviewed the log files and determined that there was no indication of any analyzer malfunction.The investigation determined the event was consistent with a sample-related issue.The investigation did not identify a product problem.

• Brand Name: COBAS B 221 6 SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• 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: 17905943
• Report Number: 1823260-2023-03243
• Device Sequence Number: 7897721
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K032311
• 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): 02/06/2024

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 Catalogue Number: 03337154001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 02/06/2024
• 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 Sex: Male