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

Catalog Number	05168449190
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	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable ca2 calcium gen.2 result from an unspecified number of patient samples tested on the cobas 8000 c702 module.The reporter was able to provide two patient samples with discrepant results: the initial results were reported outside of the laboratory.The initial results were flagged as critically low in the laboratory information system (lis) prompting the rerun of the patient samples in their other c 702 module.Sample (b)(6) the initial result from the module was 3.1 mg/dl.The repeat result from the other module was 6.6 mg/dl.Sample (b)(6) the initial result from the module was 4.1 mg/dl.The repeat result from the other module was 7.3 mg/dl.The repeat results were deemed correct.
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the analyzer and determined the system was contaminated.He then decontaminated the system; adjusted the rinse and detergent levels; and straightened the bent nozzle.The analyzer's performance was verified by calibration, qc and precision studies with successful results.The investigation reviewed the last calibration performed on (b)(6) 2024 and the results were within specifications.The investigation reviewed the qc recovery.The recovery was within the specified ranges (-2 standard deviation sd).There was no indication of a performance issue with the reagent.The investigation reviewed the alarm trace.The trace had a sample probe, sample short, and abnormal aspiration alarms.These are indicators of possible poor sample quality.The investigation reviewed the customer's handling of patient samples.The patient sample was centrifuged for 3 minutes at 5100 rpm.The centrifugation time may be too short and the speed too high according to the tube manufacturer¿s recommended guidelines.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the 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: 19512264
• Report Number: 1823260-2024-01732
• Device Sequence Number: 11617547
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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): 07/19/2024

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 Expiration Date: 11/30/2024
• Device Catalogue Number: 05168449190
• Device Lot Number: 74418501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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: 56 YR
• Patient Sex: Male