MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALCIUM GEN.2; CALCIUM TEST SYSTEM

Catalog Number	08057427190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 303 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested on a cobas c 303 analytical unit.Sample 1 had discrepant results when tested with the na electrode and cl electrode.Refer to the medwatch with a1.Patient identifier (b)(6) for information related to the na electrode and refer to the medwatch with a1.Patient identifier (b)(6) for information related to the cl electrode.Sample 1 also had discrepant results when tested with the elecsys troponin t gen 5 on a cobas pure e 402 analytical unit.Refer to the medwatch with a1.Patient identifier (b)(6) for information related to the troponin t assay.Sample 2 had discrepant results when tested with the na electrode, k electrode, cl electrode, and calcium gen.2.This medwatch will apply to the na electrode.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the na electrode.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the k electrode.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the cl electrode.A physician questioned the initial sample values so the samples were repeated.Neither the initial or repeat values were deemed correct, so the patients were re-drawn and re-tested.The first patient sample initially resulted in a na value of 120 mmol/l and it repeated as 140 mmol/l.This sample initially resulted in a cl value of 85 mmol/l and it repeated as 99.6 mmol/l.The second patient sample initially resulted in a na value of 87 mmol/l and it repeated as 144.5 mmol/l.This sample initially resulted in a k value of 2.63 mmol/l and it repeated as 4.16 mmol/l.This sample initially resulted in a cl value of 60.5 mmol/l and it repeated as 105.95 mmol/l.This sample initially resulted in a calcium value of 5.74 mg/dl and it repeated as 9.72 mg/dl.
Additional Manufacturer Narrative
The customer stated that qc recovery has been acceptable and stable.The customer suspects there was a sample handling issue related to how they are preparing their frozen samples.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: CALCIUM GEN.2
• Common Device Name: CALCIUM TEST SYSTEM
• 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: 19514943
• Report Number: 1823260-2024-01727
• Device Sequence Number: 15283210
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 06/26/2024

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: 08057427190
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/26/2024
• 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 Age: 84 YR
• Patient Sex: Female