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	12/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration signals were acceptable.The k electrodes from lot#21512951 had to be installed before the 21-january-2022.Per product labeling, the maximum in-use time of the k electrode is "23 weeks".The electrode would have needed to be discarded by the latest 01-jul-2022.The k electrode exceeded the in-use time and should not have been used on the day of the event on (b)(6) 2022.The lot number of the na electrode is unknown.The customer found that a part of the red plastic of the fill port was bent, indicating an obstruction inside the sample port, which could have interfered with the results.The customer was advised by the field service engineer to replace the fill port.Afterward, the issue did not re-occur.The investigation could not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the potassium (k) and sodium (na) electrodes on a cobas b 221 <6> system.Patient sample 1: the sample initially resulted in a k value of 7.81 mmol/l and repeated as 3.4 mmol/l on a second cobas b 221 system.Patient sample 2: the sample initially resulted in a na value of 124.8 mmol/l and repeated as 135.6 mmol/l on a second cobas b 221 system.The sample initially resulted in a k value of 16.74 mmol/l and repeated as 5.38 mmol/l on a second cobas b 221 system.The repeat results were deemed correct.No questionable results were reported outside of the laboratory.The k electrode lot number was 21512951 with an expiration date of 21-jan-2022.The na electrode lot number and expiration date were requested but not provided.

• 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: 16199621
• Report Number: 1823260-2023-00176
• Device Sequence Number: 20350191
• Product Code: CHL
• UDI-Device Identifier: 04015630014293
• UDI-Public: 04015630014293
• 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
• Report Date (Section B): 01/18/2023

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: 12/26/2022
• Initial Report FDA Received Date: 01/18/2023
• 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