MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 111 ANALYZER WITH ISE; CLINICAL CHEMISTRY ANALYZER

Model Number	C111
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
the initial reporter received questionable ise indirect na, k and ci for gen.2 results for one patient sample tested on the cobas c 111 with ise.The initial result was accidentally reported outside of the laboratory and verbally provided to the doctor.The doctor stated that they did not trust the results and because it was late, the doctor sent the patient to the emergency room (er) and another sample was collected from the patient.The patient sample was initially run on (b)(6) 2022.The reporter calibrated and reran the patient sample on (b)(6) 2022.The patient sample was again rerun on (b)(6) 2022.The repeat results of the initial sample from (b)(6) 2022 were deemed correct.The chloride electrode lot number is 21523347 with an expiration date of 03-feb-2023.The potassium electrode lot number is 21521247 with an expiration date of 23-sep-2022.The sodium electrode lot number and the expiration date were requested but not provided.
Additional Manufacturer Narrative
The field service engineer (fse) performed instrument checks with successful results.A precision check was performed with successful results.He verified that the analyzer was performing within specifications.
Additional Manufacturer Narrative
In mfr report ref #1823260-2022-04082-00, b5 - describe event or problem, the second to the last line should have been: the potassium electrode lot number is 21521247.The expiration date was requested but not provided.Instead of: the potassium electrode lot number is 21521247 with an expiration date of 23-sep-2022.
Additional Manufacturer Narrative
The qc recovery was within the acceptable range.The field service engineer (fse) performed instrument checks and no remedial actions were taken.He performed an ion-selective electrode (ise) performance check and the result was within specification.He performed a precision study with successful results.After service, no further issues were reported by the customer.  the investigation did not identify a product problem.The cause of the event could not be determined. .

• Brand Name: COBAS C 111 ANALYZER WITH ISE
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16004634
• Report Number: 1823260-2022-04082
• Device Sequence Number: 5783816
• Product Code: JJE
• UDI-Device Identifier: 04015630036189
• UDI-Public: 04015630036189
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2023

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 Model Number: C111
• Device Catalogue Number: 04777433001
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 11/22/2022; 01/05/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 12/19/2022; 01/30/2023
• 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