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

Model Number	CA G2
Medical Device Problem Codes	Unable to Obtain Readings (1516); 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	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for ca2 calcium gen.2 (ca2) on a cobas 8000 c 502 module.The initial result was 5.7 mg/dl with a data flag.The sample was automatically repeated by the instrument and the result was 5.7 mg/dl.This result was reported outside of the laboratory where repeat testing was requested.The repeat result was 10.3 mg/dl.This result was believed to be correct.The c502 module serial number was (b)(6).
Additional Manufacturer Narrative
The device code was updated.The field service engineer (fse) did not find a cause for the event.The fse performed a baseline instrument check and adjusted the gear pump pressure.Mechanical checks were performed with no issues and precision test results were within specification.The customer ran calibration and qc with no issues.Calibration was last performed on (b)(6) 2023 with acceptable results.Qc was acceptable.There was no indication of a reagent performance issue."abnormal aspiration", "sample short" and "sample foam detection" alarms were observed on the alarm trace data.These alarms are indicators of possible poor sample quality.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 16893869
• Report Number: 1823260-2023-01551
• Device Sequence Number: 6326515
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• 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,Followup
• Report Date (Section B): 07/17/2023

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: CA G2
• Device Catalogue Number: 05061482190
• Device Lot Number: 674476
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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