MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 GLU/LAC CASSETTE; ELECTRODE, ION SPECIFIC, POTASSIUM

Catalog Number	03260887184
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	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received a questionable lactate result for one patient sample tested with the cobas b 221 glu/lac cassette on a cobas b 221 6 roche omni s6 system.The customer stated that controls were 10 points different on the cobas b 221 system compared to a second cobas b 221 analyzer.The patient sample was processed on both analyzers in parallel.The result from the second cobas b 221 system was deemed correct.The sample resulted in a lactate value of 15.8 when tested on the complained cobas b 221 system.When tested on the second system, the result was 23.00 mg/dl.
Additional Manufacturer Narrative
The serial number of the cobas b 221 system is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Based on the provided information, the investigation determined the customer was using a cobas b 221 glu/lac cassette that was in use past its in-use time of 28 days.Further, the cassette was installed past its "install before" date.A product handling or sample handling related issue also could not be ruled out.The investigation did not identify a product problem.Medwatch field d4 updated.

• Brand Name: COBAS B 221 GLU/LAC CASSETTE
• Common Device Name: ELECTRODE, ION SPECIFIC, POTASSIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22815979
• Report Number: 1823260-2025-02508
• Device Sequence Number: 8756420
• Product Code: CEM
• UDI-Device Identifier: 04015630018130
• UDI-Public: 04015630018130
• Combination Product (Y/N): N
• 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): 11/03/2025

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 Expiration Date: 04/25/2025
• Device Catalogue Number: 03260887184
• Device Lot Number: 31250248
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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