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

Model Number	C111
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 2 patient samples tested for gamma-glutamyltransferase ver.2 (ggt-2) on a cobas c 111 analyzer."patient 3" initial result was 0.75 ukat/l.The repeat results were 0.29 ukat/l and 0.23 ukat/l.On (b)(6) 2021 "patient 1" initial result was 1.08 ukat/l.The repeat results were 0.33 ukat/l and 0.28 ukat/l.No questionable results were reported outside of the laboratory.The ggt-2 reagent lot number was 57220401 with an expiration date of 31-may-2022.
Additional Manufacturer Narrative
The customer stated calibration and qc were acceptable.On 29-nov-2021 the field service engineer (fse) performed preventive maintenance.The investigation is ongoing.
Additional Manufacturer Narrative
During a review of the database provided, many "sample failed to aspirate" errors were observed.The customer used a centrifugation speed of 3800 rpm for 10 minutes.Based on the type of sample tube the customer uses the centrifugation speed should be 2200 g for 15 minutes at 20°c as well as 1800 g for 10 minutes at 20°c.The investigation determined the event was due to a pre-analytical sample handling issue at the customer 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: 13044038
• Report Number: 1823260-2021-03787
• Device Sequence Number: 13890968
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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: 11/29/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/14/2022
• 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