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	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with ggt-2-glutamyl transferase ver.2 standardized against ifcc / szasz on a cobas c 111.No incorrect results were reported outside of the laboratory.The sample initially resulted in a ggt value of 505.6 u/l.The sample was repeated on a reflotron analyzer, resulting in a value of 13.9 u/l.The sample was also repeated on the c 111 analyzer, resulting in a value of 13.2 u/l.The 13.2 u/l value was deemed correct.The ggt reagent lot number and expiration date were requested, but not provided.
Additional Manufacturer Narrative
An additional measurement of the sample was performed on the reflotron, resulting in a ggt value of 12.6 u/l.
Additional Manufacturer Narrative
The calibration data was ok.Quality controls from the day of the event were not provided.Control data from 11-jan-2022 to 25-feb-2022 was within range except for one control level that was outside of range on 25-feb-2022.A general reagent issue can be ruled out as calibration and control data are acceptable.An instrument issue could also be ruled out.The investigation determined the issue is consistent with inadequate customer maintenance of the device and issues with the environmental conditions of the site.

• 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: 13578226
• Report Number: 1823260-2022-00477
• Device Sequence Number: 19935865
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2022

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: 01/31/2022
• Supplement Date Received by Manufacturer: 02/16/2022; 04/11/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/14/2022; 04/28/2022
• 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