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

Model Number	CA G2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) performed precision testing with qc material and the results were within specification.Calibration and qc were acceptable.Calibration was last performed on (b)(6) 2023 with acceptable results.Qc results were high outside of 2 standard deviations on the date of the event.After the customer recalibrated, qc was acceptable.The issue was resolved at the customer site.
Event or Problem Description
The initial reporter questioned high results for "over 100" patient samples tested for ca2 calcium gen.2 (ca2) on a cobas 6000 c (501) module.The customer re-calibrated the instrument and repeated patient samples and obtained "normal" results.Discrepant results were provided for 2 patient samples."patient 2" initial result was 12.2 mg/dl.The repeat result was 9.8 mg/dl."patient 4" initial result was 12.4 mg/dl.The repeat result was 10.2 mg/dl.No questionable results were reported outside of the laboratory.The c501 module serial number was (b)(6).

• 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: 16919269
• Report Number: 1823260-2023-01609
• Device Sequence Number: 20560572
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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: 668593
• 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: 04/18/2023
• Initial Report FDA Received Date: 05/12/2023
• 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