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	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ca2 calcium gen.2 results for 2 patient samples on a cobas 6000 c (501) module.The initial results were deemed critical and accompanied by delta check flags, which prompted the customer to repeat the samples.For sample 1, the initial ca2 result was 5.7 mg/dl.The sample was repeated on another analyzer and the result was 8.4 mg/dl.For sample 2, the initial ca2 result was 6.4 mg/dl.The sample was repeated on another analyzer and the result was 9.3 mg/dl.The repeat results were deemed correct.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) found a detergent valve was leaking, pinched and dripping tubing, an out of place sample probe spring, and a sample probe that was not retracting.The fse replaced the tubing, replaced the valve, replaced the sample probe, performed probe adjustment, replaced the ca2 reagent, checked the rinse tube rinse volume, checked the gear pump pressure, and performed an air purge, reagent prime, detergent prime, cell blank, and hardware performance check successfully.The customer performed calibration and qc successfully.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023.The qc recovery data provided was high outside of the acceptable range prior to recalibration.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 17995402
• Report Number: 1823260-2023-03410
• Device Sequence Number: 6123576
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 11/27/2023

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 05061482190
• Device Lot Number: 72663701
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/27/2023
• 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