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

Model Number	CAG2
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of discrepant low results for 2 patients' samples tested with calcium gen.2 (ca2) assay on a cobas 8000 c702 module when compared to a different cobas 8000 c702 module.Sample 1: initial result: 5.4 mg/dl.Repeat result: 9.2 mg/dl.Sample 2: initial result: 4.3 mg/dl.Repeat result: 9.1 mg/dl.Both initial results were recognized as critical results as they were shown to be below the normal range.Reportedly a corrected report was issued for sample 1.
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).Last calibration was performed on (b)(6) 2023 and was acceptable.Qc recovery level 1 had been out of range results for several days.The alarm trace showed ise measuring system 2 (sipper nozzle) alarm and sample probe up/down alarm.The field service engineer (fse) checked the rinse tubing and adjusted the position and some of the rinse levels.The fse also checked the system for drips and splashing and made minor adjustment to tube positions accordingly.Precision studies were performed and were within specifications.The customer performed qc and the results were within their limits.The service actions done resolved the issue.

• 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: 17172944
• Report Number: 1823260-2023-02033
• Device Sequence Number: 7333652
• 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): 06/21/2023

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: 01/31/2024
• Device Model Number: CAG2
• Device Catalogue Number: 05168449190
• Device Lot Number: 67147801
• 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: 05/23/2023
• Initial Report FDA Received Date: 06/21/2023
• 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