MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALCIUM GEN.2; CALCIUM TEST SYSTEM

Catalog Number	08057427190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas pro c 503 analytical unit is (b)(6).The field service engineer (fse) inspected the analyzer and determined that the event was caused by contamination of the sample probe fluidics pathway.He checked the rinse volumes, gear pump pressure, and sample probe alignment; no issues were noted.He then decontaminated the sample probe fluidics pathway.He performed a precision check using controls (20 times) with successful results.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable calcium gen.2 (ca2) results from two patient samples tested on the cobas pro c 503 analytical unit.The initial results were reported outside of the laboratory.Sample id: (b)(6).The patient sample was rerun according to the physician's request.The initial result was 3.1 mg/dl.The repeat result was 7.24 mg/dl.This result was deemed correct.Sample id: (b)(6).The patient sample was rerun because the initial result was deemed low.The initial result was 5.73 mg/dl.The first repeat result was 7.64 mg/dl.This result was deemed correct.The second repeat result was 8.38 mg/dl.
Additional Manufacturer Narrative
The investigation reviewed the provided autocalibration data; no alarms were noted.The investigation reviewed the qc data; qc level 1 was 8.61 mg/dl (expected result 8.31 mg/dl on the date of event) and qc level 2 was consistently 13.0 mg/dl (expected result 12.93 mg/dl).The qc was acceptable.The investigation reviewed the alarm trace; the trace contained one calibration alarm.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: CALCIUM TEST SYSTEM
• 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: 18686025
• Report Number: 1823260-2024-00400
• Device Sequence Number: 17875924
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 03/06/2024

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 Catalogue Number: 08057427190
• Device Lot Number: 755465
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/06/2024
• 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 Age: 71 YR
• Patient Sex: Unknown