MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C502
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned low results for 10 patient samples tested for online tdm valproic acid (valp2) on a cobas 8000 c 502 module.For all 10 patient samples, the initial result was 0.1 ug/ml with a data flag.When the samples were repeated, the results were "much higher." the customer provided specific results for 1 patient sample.The initial result was 0.1 ug/ml with a data flag.The repeat result was 74.9 ug/ml.The questionable low results were reported outside of the laboratory.The valp2 reagent lot number was 63608501 with an expiration date of 30-nov-2023.
Additional Manufacturer Narrative
The field service engineer (fse) adjusted the gear pump head, sample probe wash, and the reaction disk light pass.The fse performed a 21-cup precision with acceptable results.The customer calibrated and ran qc with acceptable results.The system was operating within specification.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023 with acceptable results.Qc was acceptable.There was no indication of a reagent performance issue.The service actions resolved the issue.

• Brand Name: COBAS 8000 C 502 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: 16306734
• Report Number: 1823260-2023-00360
• Device Sequence Number: 17623949
• Product Code: JJE
• UDI-Device Identifier: 04015630999385
• UDI-Public: 04015630999385
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• 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,Followup
• Report Date (Section B): 02/28/2023

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: C502
• Device Catalogue Number: 05964067001
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 02/28/2023
• 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