MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C111; CLINICAL CHEMISTRY ANALYZER

Model Number	C111
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
There was a complaint of questionable ise potassium electrode results for 1 patient tested with a cobas c111 with ise module.The questionable results were not reported outside the laboratory.The patient was tested on 2 c111¿s (modules a and b) and one reflotron analyzer.The patient¿s initial result on module a was 5.53 mmol/l; the repeat on module b was 3.83 mmol/l, the third repeat on the reflotron was 3.76 mmol/l.The lot number and expiration date of the ise potassium electrode used were requested, but not provided.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) found the ise waste tank and tubing were clogged with an unknown lipidic substance and replaced electrodes.The service actions resolved the issue.No further issues were reported for "at least 1 month", then the issues "reoccurred again with the same pattern".When the issue reoccurs, the customer states the calibration of sodium (na+) and potassium (k+) start to fail.The reason for the accumulation of the lipidic substances could not be determined and is an isolated occurrence.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS C111
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13052812
• Report Number: 1823260-2021-03812
• Device Sequence Number: 19805409
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K071211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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 Model Number: C111
• Device Catalogue Number: 04777433001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 03/02/2022
• 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: Female