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

Model Number	CA GEN.2
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the first cobas integra 400 plus analyzer is (b)(6) and the second integra 400 plus analyzer serial number is (b)(6).A field service engineer visited the site and determined that the customer's water quality does not meet specifications.The engineer performed calcium measurements using the customer's water and the color obtained was the same as tap water where untreated water arrives.The instruments were decontaminated.After this, a significant improvement was noticed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for an unspecified number of patient samples tested for multiple parameters on two cobas integra 400 plus analyzers.The customer provided data for one patient sample that had discrepant results when tested with calcium gen.2.The sample initially resulted in a calcium value of 15.33 mg/dl when tested on the first integra 400 plus analyzer.The sample was repeated on the second integra 400 plus analyzer, resulting in a calcium value of 17.0 mg/dl.The sample was then repeated on an unknown analyzer outside of the laboratory, resulting in a calcium value of 8 mg/dl.This value was considered to be correct by the customer.
Additional Manufacturer Narrative
After decontamination and switching to the proper water quality, no further issues occurred.The investigation determined the issue was related to the incorrect water type used by the customer.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22307972
• Report Number: 1823260-2025-01915
• Device Sequence Number: 8655318
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/17/2025

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 GEN.2
• Device Catalogue Number: 05061482190
• Device Lot Number: 82133401
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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