MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 311 ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	C311
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable creatinine jaffe, gen 2 result from the cobas 4000 c311 system.The initial result was 4.43 mg/dl with a data flag and was reported outside of the laboratory to the doctor.As the result did not coincide with the patient's medical history, the doctor requested repeat testing.On 13-oct-2022, the same sample was retested on the same analyzer with a result of 2.09 mg/dl and on a cobas c501 analyzer with a result of 1.80 mg/dl.The repeat result was believed correct.The reagent lot number was 63597001 with an expiration date of 31-jan-2024.
Additional Manufacturer Narrative
A general reagent problem could be ruled out because calibration and quality control were acceptable.It was found that the customer is not cleaning the probes on a daily basis as recommended.Therefore a carry-over event can not be excluded.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS C 311 ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15742555
• Report Number: 1823260-2022-03511
• Device Sequence Number: 20601519
• Product Code: JJE
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K060373
• 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
• Report Date (Section B): 12/08/2022

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: C311
• Device Catalogue Number: 04826876001
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/08/2022
• 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