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	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and expiration date were not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable glucose results for 1 patient sample on a cobas b 221 6 system.The initial result was 245.9 mg/dl.The repeated result was 26.7 mg/dl.The repeated result was obtained on another b 221 instrument.
Additional Manufacturer Narrative
The result of 245.9 mg/dl was believed to be correct because it matches the patient's clinical condition.The investigation found that the metabolite-sensitive sensor (mss) cassette had an "install before" date of (b)(6) 2024.The cassette had expired before the alleged event.Product labeling states: "using expired mss cassettes and/or mss cassettes that have exceeded their maximum in-use time may lead to incorrect results.Data collected using expired mss cassettes and/or mss cassettes that have exceeded their maximum in-use time are not reliable.This may lead to incorrect results, which may endanger patient lives.Do not install mss cassettes after the "install before" date.Do not use mss cassettes after their maximum in-use time." 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: 19658807
• Report Number: 1823260-2024-01924
• Device Sequence Number: 15181995
• 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): 08/20/2024

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: 06/07/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/21/2024
• 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