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

Catalog Number	03337154001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ise indirect k for gen.2 results for two patient samples tested on the cobas b 221 6 roche omni s6 system.The initial result was reported to the medical personnel.Patient 1: the initial result from the b 221 was 7.07 mmol/l.The repeat result from the b 221 was 4.48 mmol/l.Patient 2: the initial result from the b 221 was 8.96 mmol/l.The patient sample was rerun on another laboratory instrument and the repeat result was 7.2 mmol/l.The electrode lot number is 21524047.The expiration date was requested but not provided.
Additional Manufacturer Narrative
The customer changed all of the electrodes in the ion-selective (ise) line, fill port, needle, and sample inlet path (sip).These parts were not available for investigation as the customer discarded them.The patient comparison results did not indicate any issues after the parts were replaced.The provided log files did not cover the date of the event.Based on database extracts, the reported k electrode was installed on (b)(6) 2023 and was valid for use on the date of the event.The calibration for the k electrode was within the limit for both 1-point and slope calibrations.The qc levels were within specifications around the date of the event.The only recurring errors were 10471 - "t&d error": "t&d disk, fill port or plug control are very contaminated or damaged.Clean the relevant components or if necessary replace".The instrument also warned to perform maintenance.The investigation determined the customer's actions (replacing the electrodes, fill port, needle, and sip) resolved the issue.Based on the information provided, the cause of the event could not be determined.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16773018
• Report Number: 1823260-2023-01331
• Device Sequence Number: 19646452
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 04/19/2023

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): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/19/2023
• 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
• Patient Sex: Unknown