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

Model Number	CA GEN.2
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable calcium gen.2 results for 1 patient sample on a cobas 8000 c702 module.The initial calcium result was 11.46 mg/dl.The sample was repeated and the result was 9.32 mg/dl.The sample was also repeated twice on another c702 analyzer and the results were 9.72 mg/dl and 9.74 mg/dl.
Additional Manufacturer Narrative
On (b)(6) 2025, questionable results for 14 more patient samples were provided.For sample 2, the initial calcium result was 5.62 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.65 mg/dl.The initial analyzer was recalibrated and the sample was repeated two times and the results were 9.51 mg/dl and 9.79 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 9.1 mg/dl.For sample 3, the initial calcium result was 7.45 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.6 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 10.46 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 9.05 mg/dl.For sample 4, the initial calcium result was 6.58 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.34 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.26 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 8.79 mg/dl.For sample 5, the initial calcium result was 10.78 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.41 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.37 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 8.87 mg/dl.For sample 6, the initial calcium result was 12.58 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.63 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.58 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 9.28 mg/dl.For sample 7, the initial calcium result was 7.87 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.87 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.66 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 9.35 mg/dl.For sample 8, the initial calcium result was 7.11 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.82 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.82 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 9.37 mg/dl.For sample 9, the initial calcium result was 7.38 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.83 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.84 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 9.36 mg/dl.For sample 10, the initial calcium result was 11.42 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.52 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.52 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 9.08 mg/dl.For sample 11, the initial calcium result was 7.93 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.51 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.71 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 9.07 mg/dl.For sample 12, the initial calcium result was 5.78 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.17 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.16 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 8.62 mg/dl.For sample 13, the initial calcium result was 12.36 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.36 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.39 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 8.89 mg/dl.For sample 14, the initial calcium result was 6.98 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.48 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.42 mg/dl.The sample was repeated again on a third c702 analyzer and the result was 8.92 mg/dl.For sample 15, the initial calcium result was 5.56 mg/dl.The sample was repeated on another c702 analyzer and the result was 9.87 mg/dl.The initial analyzer was recalibrated and the sample was repeated.The result was 9.63 mg/dl.The sample was repeated again on a third c702 analyzer twice and the results were 9.24 mg/dl and 9.14 mg/dl.

• 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: 22953044
• Report Number: 1823260-2025-02712
• Device Sequence Number: 13228604
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: 05168449190
• Device Lot Number: 822631
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/29/2025
• 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