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

Catalog Number	05168449190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable calcium gen.2 result from the cobas 8000 c702 module.The initial result was 3.15 mmol/l and was reported outside of the laboratory.The clinician felt it was not consistent with the patient's clinical manifestations and requested repeat testing.The repeat result on the same analyzer was 2.41 mmol/l.The repeat result on another cobas c702 analyzer was 2.47 mmol/l.
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18159347
• Report Number: 1823260-2023-03649
• Device Sequence Number: 15453463
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 12/08/2023

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: 08/31/2024
• Device Catalogue Number: 05168449190
• Device Lot Number: 721396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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