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

Model Number	CA GEN.2
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 501 analyzer is (b)(6).The field service engineer ran precision studies and these recovered within guidelines.The investigation is ongoing.
Event or Problem Description
The customer stated they received questionable results for an unspecified number of patient samples tested with calcium gen.2 on a cobas 6000 c 501 analyzer.The customer stated that they performed maintenance and loaded system reagents.Calibration and controls passed.They began running patient samples, but noticed that calcium values were lower than expected.The customer then loaded a new reagent pack and controls recovered within range.Patient samples were repeated, but they were still getting the same low results.The customer then borrowed a reagent pack from another site and repeated patient samples using it.The pack from the other site generated expected patient values.The customer provided one example of a sample with discrepant calcium results.The sample resulted in a calcium value of 5.6 mg/dl when using the customer's reagent pack.When tested using the pack from the other site, the calcium result was 7.8 mg/dl.The repeat value was deemed correct.
Additional Manufacturer Narrative
Calibration and control data were acceptable.There was no indication of a reagent performance issue.The investigation determined the issue is consistent with a reagent shipment handling issue.The customer obtained a new reagent of the same lot from a nearby account and samples recovered as expected.

• 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: 21718475
• Report Number: 1823260-2025-00921
• Device Sequence Number: 9418906
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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 Expiration Date: 11/30/2025
• 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): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/16/2025
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 119 KG