MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CA2; 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	07/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ca2 calcium gen.2 results for 4 patient samples on a cobas 8000 c 702 module.The customer was prompted to repeat the samples as the results were low.For patient 1, the initial ca2 result was 6.4 mg/dl.The repeat result from another analyzer was 8.8 mg/dl.For patient 2, the initial ca2 result was 4.9 mg/dl.The repeat result from another analyzer was 9.2 mg/dl.For patient 3, the initial ca2 result was 5.2 mg/dl.The repeat result from another analyzer was 7.8 mg/dl.For patient 4, the initial ca2 result was 7.7 mg/dl.The repeat result from another analyzer was 9.3 mg/dl.The repeat results were deemed correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023.The qc recovery data provided was acceptable.Based on the calibration and qc data, a general reagent performance issue could be excluded.The alarm trace showed an abnormal volume of reagent disk a alarm, a reagent pipettor alarm, and an incubator bath water alarm.The field service engineer (fse) found leaking vacuum tubing and replaced it, adjusted all nozzles, and checked all sample and probe adjustments and rinse pressures.The customer performed calibration and qc successfully.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg)
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 17465473
• Report Number: 1823260-2023-02519
• Device Sequence Number: 11399414
• Product Code: CHW
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 09/07/2023

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: 03/31/2024
• Device Catalogue Number: 05168449190
• Device Lot Number: 69403301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/07/2023
• 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 Age: 75 YR
• Patient Sex: Female