MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALCIUM GEN. 2; TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM

Model Number	CA GEN.2
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ca2 calcium gen.2 results from 567 patient samples tested on the cobas 8000 c702 module.The reporter stated that they noted the variation in qc and patient results when they started using the reported reagent lot.The reporter was able to provide one patient sample with discrepant results: the initial result was 9.6 mg/dl.The repeat result was 7.7 mg/dl.The initial result was not reported outside the laboratory as it was deemed incorrect.The repeat result was deemed correct.
Additional Manufacturer Narrative
The serial number of the cobas 8000 c702 module is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the 20-aug-2024 calibration data; the calibration was acceptable but the signals changed compared to the previous reagent lot.The investigation reviewed the qc recovery; the recoveries were erratic and showed both high and low recoveries either at the 2 standard deviation range or close to out of range.This is an indication of a possible reagent issue.The field service representative inspected the module and indicated that the recovery issue started with the reported reagent lot.The customer changed the reagent lot and obtained acceptable qc results.The customer did not report any other issues after service.The investigation determined the service actions resolved the issue.

• Brand Name: CALCIUM GEN. 2
• Common Device Name: TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20214895
• Report Number: 1823260-2024-02666
• Device Sequence Number: 12625072
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K113521
• 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): 11/11/2024

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: CA GEN.2
• Device Catalogue Number: 05168449190
• Device Lot Number: 790795
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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