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

Catalog Number	08057427190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable calcium gen.2 results for 2 patients on a cobas c 503 analytical unit.Patient 1: the initial result was 2.65 mmol/l.The sample was repeated and the result had an invalidating flag.The sample was repeated (after centrifugation) again on another analyzer and the result had an invalidating flag.The sample was repeated (after centrifugation) on the initial analyzer and the result was 1.91 mmol/l.The sample was repeated (after centrifugation) on another analyzer and the result was 1.96 mmol/l.Patient 2: on (b)(6) 2024 the initial result was 2.94 mmol/l.The sample was repeated and the result had an invalidating flag so the sample was repeated again (after a new centrifugation) and the result was 2.52 mmol/l.The samples were repeated due to the laboratory's rule to repeat samples with results that are >2.55 mmol/l without the patient having prior results <48 hours.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The samples were centrifuged at 2250g for 10 minutes.The samples were requested to be returned for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Samples were provided for investigation.The customer's results were not confirmed.It was noted the instrument's main water pressure was out of specification.The system's alarm trace showed sample short and sample aspiration alarms.The alarms are indicative of poor sample quality.The investigation did not identify a product problem and determined the issue was consistent with a sample quality 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: 19106665
• Report Number: 1823260-2024-01156
• Device Sequence Number: 18107389
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 08/27/2024

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 Expiration Date: 03/31/2025
• Device Catalogue Number: 08057427190
• Device Lot Number: 76942201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 08/27/2024
• 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 Sex: Unknown