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

Model Number	C111
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's provided calibration results on (b)(6) 2022 were not acceptable due to calibration alarms.The calibration results prior to the event were requested but not provided.The customer's qc results were within the acceptable ranges.There was no indication of a performance issue with the reagent.The customer's sample pre-analytical details were requested but not provided.The investigation did not find any abnormalities in the customer's system alarm trace.The field service engineer found an issue with the reference electrode.He replaced all of the ise electrodes.After service, no further issues were reported by the customer.The date of installation for the reference electrode was requested but not provided.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter received questionable ise indirect gen.2 na results for seven patients tested on a cobas c 111 analyzer with ise.The reporter stated the field service engineer previously serviced the c 111 analyzer.Due to high na results, the reporter completed a correlation study with patient samples.Prior to patient testing, the reporter confirmed the qc was acceptable on the c 111 analyzer.The samples were initially tested on the reporters c 111 analyzer and then the samples were sent to two different laboratories for testing on a cobas 6000 c (501) module and a c 111 analyzer.The customer was unsure which na result was reported outside the laboratory for each patient but determined the results at the other facilities were correct.(b)(6).The na electrode lot number was 21514366 and the expiration date was requested but not provided.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13995243
• Report Number: 1823260-2022-00942
• Device Sequence Number: 14781638
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• 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
• Report Date (Section B): 04/04/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/04/2022
• 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: Unknown