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

Catalog Number	08057427190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable calcium gen.2 (ca2) results from multiple patient samples tested on the cobas c 503 analytical unit.The customer stated that their water system was serviced on 01-may-2024 and that they started receiving low calcium results from the analyzer on 03-may-2024.The reporter was able to provide two examples of discrepant results: the initial results were reported outside of the laboratory.The delta check flag in the middleware prompted the rerun of the patient samples.Sample (b)(6).The initial result was 8.4 mg/dl with a data flag.The repeat result was 10.1 mg/dl.Sample (b)(6) the initial result was 6.9 mg/dl with a data flag.The repeat result was 8.7 mg/dl.The repeat results were deemed correct.
Additional Manufacturer Narrative
The reagent lot number is 755465.The expiration date was not provided.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.On the field service engineer's (fse) initial service visit, he analyzed the calibration trace and found that the calibration technically passed but the set points were not in line with previous calibrations.Recalibration was then performed resulting in new set points that looked normal.The customer performed qc and a precision check using qc level 1 with acceptable results.On the fse's follow-up visit, he instructed the customer to flush the system after water maintenance was done.The customer performed a precision check and qc with acceptable results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.The investigation did not identify a product problem.

• 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 46250-0457
• MDR Report Key: 19415081
• Report Number: 1823260-2024-01590
• Device Sequence Number: 6540219
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 07/03/2024
• 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: 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: 05/07/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/03/2024
• 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: 51 YR
• Patient Sex: Female