MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALCIUM GEN. 2; TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM

Catalog Number	05061482190
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	03/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with calcium gen.2 on a cobas integra 400 plus.The sample initially resulted in a calcium value of 15.7 mg/dl.The patient questioned the result.The sample was repeated, resulting in a calcium value of 9.5 mg/dl.
Additional Manufacturer Narrative
The integra 400 plus analyzer serial number is (b)(6).Quality controls were acceptable on the day of the event.The customer stated that calibration was acceptable.No sample related alarms were observed.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue was excluded since calibration and qc data were acceptable.The investigation did not identify a specific product problem.The cause of the event could not be determined.The issue was consistent with pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.

• Brand Name: CALCIUM GEN. 2
• 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: 19159667
• Report Number: 1823260-2024-01232
• Device Sequence Number: 18101321
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• 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): 05/08/2024

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: 05061482190
• Device Lot Number: ASKU
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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