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	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The last maintenance was performed on (b)(6) 2023.On (b)(6) 2023 and on (b)(6) 2023, qc results showed increased k values.On (b)(6) 2023 the customer changed the fill port and cleaned an instrument part.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's samples tested with potassium (k) on a cobas b221 6 omni s6 system.On (b)(6) 2023 the following results were obtained: sample 1 (type unknown) at 12:57 p.M.Resulted in 3.78 mmol/l.Sample 2 (arterial) at 12:59 p.M.Resulted in 10.87 mmol/l.Sample 3: a new sample was taken (arterial) at 2:22 p.M.And resulted in 4.23 mmol/l.Sample 4 at 2:24 p.M.The result was more than 20 mmol/l (accompanied with a data flag).Sample 5 at 3:22 p.M.The result was more than 20 mmol/l (accompanied with a data flag).Sample 6 (serum) was tested on a different analyzer at 2:31 p.M.And resulted in 4.4 mmol/l.Sample 7: a new sample was taken (type unknown) at 2:35 p.M.And resulted in 12.56 mmol/l.Sample 8: a new sample was taken (type unknown) at 3:43 p.M.And resulted in 11.92 mmol/l.Sample 9 (serum) was tested on a different b221 analyzer at 5:53 p.M.And resulted in 3.9 mmol/l.Sample 10 was tested on a different b221 analyzer at 6:26 p.M.And resulted in 4.0 mmol/l.Sample 11: the same blood sample was then tested at 6:28 p.M.And resulted in 3.2 mmol/l.It is unknown at this time if samples 9 and 10 were repeat measurements from one of the first 5 samples.Different staff members were taking the blood samples.
Additional Manufacturer Narrative
No questionable results were reported outside the laboratory.The customer stated that the instrument went through a deep clean and all suitable parts were replaced.Based on the data no analyzer and/or spare part consumable issues were found.The investigation determined that the alleged sample was already hemolyzed when it was detected by the analyzer.The root cause for this issue was unclear, however, it is consistent with a pre-analytical handling issue.The investigation did not identify a product problem.No further issues were reported afterward.

• 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: 17563443
• Report Number: 1823260-2023-02664
• Device Sequence Number: 6940161
• 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): 11/21/2023

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: 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: 07/22/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 11/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HIGH DOSE VASOPRESSORS
• Patient Sex: Unknown