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

Catalog Number	05061482190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with calcium gen.2 on a cobas 6000 c 501 analyzer.The customer noted that the issue occurred after maintenance was performed on the laboratory water system.The initial values were questioned by a physician since they did not match the history of the patients.The samples were repeated and the repeat values were deemed correct.Corrected reports were issued.The first sample initially resulted in a calcium value of 11.6 mg/dl and it repeated as 9.4 mg/dl.The second sample initially resulted in a calcium value of 12.5 mg/dl and it repeated as 10.3 mg/dl.
Additional Manufacturer Narrative
One control level was outside of range on the day of the event.A second control level recovered within range on the day of the event.Upon review of the alarm trace, no relevant alarms were observed.It was determined that the customer's water system underwent maintenance activities prior to the event.Deionized water was run through the system and the customer verified quality control recovery.No further issues occurred.Water requirements are within the customer's responsibility.The investigation did not identify a product issue.

• 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: 19732325
• Report Number: 1823260-2024-02014
• Device Sequence Number: 12551620
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 08/14/2024

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): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/14/2024
• 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