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

Catalog Number	05168449190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable ca2 calcium gen.2 result from one patient sample tested on the cobas 8000 c702 module.The doctor questioned the result prompting the rerun of the patient sample.A new sample was also collected from the patient.The initial result of the initial sample was 2.86 mmol/l.The repeat result of the initial sample was 2.18 mmol/l.This result was deemed correct.The result of the new sample was 2.24 mmol/l.
Additional Manufacturer Narrative
A.Patient information and b7 other relevant history were updated.In mfg report no1823260-2023-03018, the third to fifth line of b5 describe event or problem should have been: "on (b)(6) 2023, the initial result of the initial sample was 2.86 mmol/l.On (b)(6) 2023, the initial result of the new sample was 2.24 mmol/l.On (b)(6) 2023, the repeat result of the initial sample was 2.22 mmol/l.On (b)(6) 2023, the repeat result of the new sample was 2.18 mmol/l.This result was deemed correct." instead of: "the initial result of the initial sample was 2.86 mmol/l.The repeat result of the initial sample was 2.18 mmol/l.This result was deemed correct.The result of the new sample was 2.24 mmol/l." the investigation reviewed the last calibration performed; the results were within specifications.The investigation reviewed the qc recovery; the level 1 qc recovery from 25-jul-2023 to 24-aug-2023 was within +/- 2 standard deviation (sd) range and was within specifications; the level 2 qc recovery from 25-jul-2023 to 24-aug-2023 was within +/- 2 standard deviation (sd) range and was within specifications.The investigation reviewed the alarm trace provided from 20-aug-2023 to 22-aug-2023; the alarm "abnormal aspiration (sample probe)" occurred frequently.The investigation determined the event was consistent with a preanalytic issue at the customer site (frequent occurrence of the "abnormal aspiration - sample probe" alarms).Preanalytics are within the customer's responsibility.The investigation did not identify a product problem.

• 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: 17772175
• Report Number: 1823260-2023-03018
• Device Sequence Number: 17897963
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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 Catalogue Number: 05168449190
• Device Lot Number: 694033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 12/27/2023
• 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 Age: 85 YR
• Patient Sex: Male