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

Catalog Number	05061482190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca2 reagent lot number and expiration date were not provided.The qc was acceptable on the morning of the event but it went extremely low after running the patient samples.The field service engineer performed a full instrument check and found that the reagent pack was not good.He inspected the rinse tubings, the gear pump head pressure, and the rinse level in the cells.No hardware problem was found.The customer replaced the ca2 reagent pack.Calibration and qc were performed and they passed successfully.The customer then ran patient samples and the results were as expected.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 3 patients' plasma samples tested with calcium gen.2 (ca2) assay on a cobas 6000 c501 analyzer.Sample 1: initial result: 0.24 mmol/l.Repeat result: 2.33 mmol/l.Sample 2: initial result: 0.23 mmol/l.Repeat result: 2.30 mmol/l.Sample 3: initial result: 0.23 mmol/l.Repeat result: 2.31 mmol/l.Two out of the three results were not reported outside the laboratory.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
A new reagent pack was put on the instrument and calibrated on 27-nov-2023.The same pack was calibrated on 27-nov-2023 and 28-nov-2027 with no alarms noted.The original reagent pack was last calibrated on 28-nov-2023 and showed "standard error" alarms.The alarm trace showed multiple alarms including bath water level sensor alarm, controller alarm, and cell rinse cleaner short alarm.During the investigation, the customer reported that they adjusted the calibration standard for ca from 0.0 to 0.00 and most likely did not account for the stand-by reagent pack on board.The investigation did not identify a product problem.The cause was consistent with a user error.The troubleshooting activities (replacing the ca2 reagent pack) performed by the customer resolved the issue.No further issues were reported afterward.

• 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 46250-0457
• MDR Report Key: 18335910
• Report Number: 1823260-2023-04040
• Device Sequence Number: 2466114
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 02/01/2024
• 2 Devices were Involved in the Event: 1 2

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: 743031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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