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

Catalog Number	03337154001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 2 patients whole blood samples tested for potassium (k) on a cobas b221 6 roche omni s6 system compared to a different cobas b221 6 roche omni s6 system.Sample (b)(6) (patient (b)(6)): initial result: 9.21 mmol/l (tested from arterial blood).Repeat result: 2.96 mmol/l (tested from arterial blood on another cobas b221 6 roche omni s6 system).Sample (b)(6) (patient (b)(6)): initial result: 8.70 mmol/l (tested from venous blood).Repeat result: 4.01 mmol/l (tested from arterial blood on another cobas b221 6 roche omni s6 system).The customer questioned the initial results and repeated the samples on another cobas b221 6 roche omni s6 system within a few minutes.No questionable results were reported outside the laboratory.The repeat results were considered to be correct as they matched the patients' history.
Additional Manufacturer Narrative
The k electrode expiration date was not provided.The cobas b221 6 roche omni s6 system serial number was 26199.The sample was processed immediately when it arrived at the laboratory and the syringes used had an anticoagulant.The k and the reference electrodes of the ise chamber were requested for investigation on 25-jul-2024 but the customer mentioned that they will not be provided.The investigation is ongoing.
Additional Manufacturer Narrative
Sections d1, d2a, d2b, and d4 were updated.The k electrode lot number was 31231647.Calibration and qc were acceptable.The k electrode should have been replaced no later than (b)(6) 2023 and, therefore, it was used past its maximum in-use time.The data analysis conducted revealed no instrument-related issues and that the k electrode was used beyond the maximum in-use time, constituting an off-label use.The investigation did not identify a product problem.The cause of the event was not following the instrument's instructions for use which potentially led to consumables exceeding their specified maximum in-use time along with improper sample handling.

• 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 46250-0457
• MDR Report Key: 20011817
• Report Number: 1823260-2024-02391
• Device Sequence Number: 19924121
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): Y
• Initial Reporter Country: AR
• 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): 10/14/2024

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
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/14/2024
• 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
• Patient Sex: Unknown