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

Model Number	CAG2
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) did machine adjustment and a performance check.The system was working properly without any problems.Precision studies were performed and they were within specifications.On review of the alarm trace, abnormal aspiration and sample short errors were observed.These are indicators of possible poor sample quality.No further issues were reported after the service actions.The investigation could not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
We received an allegation of questionable results for 1 patient sample tested with calcium gen.2 (ca2) assay on a cobas 8000 c701 module serial number (b)(4).On (b)(6) 2023 the customer ran the sample and it resulted in an initial calcium value of 6.71mg/dl.The lis flagged the result as critical which prompted the rerun of the results.On (b)(6) 2013 the customer repeated the test and the calcium result was 9.17mg/dl.The results were reported outside of the laboratory.The repeat results deemed to be the correct results.The last calibration performed was on 6-feb 2023 and was acceptable.The laboratory performed qc on the days of the testing and they all passed.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16549144
• Report Number: 1823260-2023-00820
• Device Sequence Number: 17708507
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/15/2023

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 Expiration Date: 11/30/2023
• Device Model Number: CAG2
• Device Catalogue Number: 05168449190
• Device Lot Number: 65487201
• 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: 02/16/2023
• Initial Report FDA Received Date: 03/15/2023
• 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