MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CA2; TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM

Catalog Number	05168449190
Medical Device Problem Codes	Mechanical Problem (1384); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned low results for multiple patient samples tested for calcium (ca) on a cobas 8000 c 702 module.The customer repeated patient samples and discrepant results were identified for 3 patient samples.Patient 1 initial result was 7.0 mg/dl.The repeat result was 9.3 mg/dl."patient 3" initial result was 6.4 mg/dl.The repeat result was 8.6 mg/dl."patient 4" initial result was 6.2 mg/dl.The repeat result was 8.6 mg/dl.The repeat results were believed to be correct.
Additional Manufacturer Narrative
The ca reagent lot number and expiration date were not provided.The customer ran qc and it was out of the acceptable range.The customer replaced the reagent pack and calibrated it.Qc was acceptable.The field service engineer (fse) inspected various parts of the instrument and ran a 21-cup precision with acceptable results.Qc was acceptable.
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).Based on the data provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: CA2
• 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 46250-0457
• MDR Report Key: 18483125
• Report Number: 1823260-2024-00106
• Device Sequence Number: 9016743
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 05168449190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/02/2024
• 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 Age: 84 YR
• Patient Sex: Female