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

Catalog Number	05168449190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient serum sample tested with calcium gen.2 (ca2) assay on a cobas 8000 cobas c701 analyzer.Initial result: 0.01 mmol/l.1st repeat result: 0.04 mmol/l.On (b)(6) 2024 the sample was repeated for the 2nd time.2nd repeat result: -0.02 mmol/l.The customer questioned the results as they looked very low/unbelievable, and therefore, no questionable result was reported outside the laboratory.The customer stated that the results were not accompanied by data flags although they were obtained below the measuring range (0.2 mmol/l).
Additional Manufacturer Narrative
The ca2 reagent expiration date was not provided.The cobas c701 module serial number was (b)(6).Qc was within the assigned ranges on the day of the events.The investigation is ongoing.
Additional Manufacturer Narrative
The cause of the test measurements was consistent with a mix-up of sample tubes or the pour-over of an ethylenediaminetetraacetic acid (edta) tube into a serum tube.The investigation did not identify a product problem.The root cause was consistent with a preanalytic issue/sample handling at the customer's site.Preanalytics are within the customer's responsibility.

• 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
• MDR Report Key: 18915029
• Report Number: 1823260-2024-00776
• Device Sequence Number: 6769310
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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 Catalogue Number: 05168449190
• Device Lot Number: 744185
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/19/2024
• 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 Sex: Unknown