MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CA2; TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM

Catalog Number	05061482190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for two patient samples tested with ca2 (calcium) on a cobas 4000 c311 stand alone system.The first patient sample initially resulted in a calcium value of 4.5 mg/dl.The doctor questioned the result.The same sample was repeated, resulting in a value of 9.2 mg/dl.The repeat value was deemed correct.The second patient sample resulted in a calcium value of 5.3 mg/dl.The doctor questioned the result.A second sample was then collected from this patient and this sample resulted in a calcium value of 8.7 mg/dl.The repeat measurement was deemed correct.
Additional Manufacturer Narrative
The serial number of the c311 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer determined the rinse mechanism water flow was low and there was possible system contamination.The system was decontaminated and the rinse volume was adjusted.Calibration and controls were run.The investigation determined the service actions resolved the issue.

• Brand Name: CA2
• 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: 17769186
• Report Number: 1823260-2023-03014
• Device Sequence Number: 20367487
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 10/20/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/20/2023
• 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