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

Catalog Number	08057427190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable calcium gen.2 (ca2) result from multiple patient samples tested on the cobas c 303 analytical unit - emc.The reporter was able to provide two examples of discrepant results: the initial results were not reported outside of the laboratory as high results were observed in the line prompting the rerun of the patient samples.Sample (b)(6) the initial result was 12.5 mg/dl.The repeat result was 9.5 mg/dl.Sample (b)(6) the initial result was 12.4 or 12.5 mg/dl.The repeat result was 9.6 mg/dl.The repeat results were deemed correct.
Additional Manufacturer Narrative
The field service engineer (fse) determined the event was caused by insufficient patient sample volume in the tube.The customer reran the patient sample with sufficient patient sample volume and no other issues were noted.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: 19114870
• Report Number: 1823260-2024-01164
• Device Sequence Number: 7099617
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 07/08/2024

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: ASKU
• 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: 03/23/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/08/2024
• 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 Sex: Unknown