MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable low valproic acid (valp2) result from the cobas 6000 c501 module.The initial result was 0.8 ug/ml with a data flag and was reported outside of the laboratory.The repeat results were 30.1 ug/ml and 45.4 ug/ml.The repeat results on 27-oct-2022 were 51.1 ug/ml and 45.2 ug/ml.The reagent lot number and expiration date were requested but were not provided.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The calibration and qc data were acceptable.The analyzer alarm trace did not show any serious alarms.
Additional Manufacturer Narrative
Medwatch fields a2 - age at time of event, 2 - date of birth, a3 - sex, b3 - date of event, and medications were updated.The results of 30.1 ug/ml and 45.4 ug/ml were obtained on (b)(6) 2022.The reagent lot number was 598405.

• Brand Name: COBAS 6000 C501 MODULE
• 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: 15798177
• Report Number: 1823260-2022-03627
• Device Sequence Number: 4790566
• Product Code: JJE
• UDI-Device Identifier: 04015630998913
• UDI-Public: 04015630998913
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 12/27/2022

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: C501
• Device Catalogue Number: 04745914001
• 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: 10/28/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 12/14/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/06/2022; 12/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VALPROICO
• Patient Age: 52 YR
• Patient Sex: Female