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	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable calcium (ca2) assay results from five patient samples tested on the cobas pro c 503 analytical unit with serial number (b)(6).It was asked, but it is not known if the initial results were reported outside of the laboratory.On (b)(6) 2023: sample 1 the initial result from line 1 was 3.02 mmol/l.The repeat result from line 2 was 1.94 mmol/l.On (b)(6) 2023: sample 942831986s0 - the initial result from line 1 was 2.64 mmol/l.The first repeat result from line 1 was 2.37 mmol/l.The second repeat result from line 2 was 2.19 mmol/l.Sample 942831984s0 - the initial result from line 1 was 2.77 mmol/l.The repeat result from line 2 was 2.28 mmol/l.Sample 942813982s0 -the initial result from line 1 was 2.68 mmol/l.The repeat result from line 2 was 2.18 mmol/l.Sample 942831983s0 - the initial result from line 1 was 2.74 mmol/l.The repeat result from line 2 was 2.26 mmol/l.
Additional Manufacturer Narrative
There were about 4-5 "abnormal aspiration" alarms on the instrument.The main water supply pressure was above 70.This water supply pressure is too high and would affect the sample and reagent probe wash.The main water supply pressure setting should be between 55-60.The investigation determined that the event was due to a maintenance issue (water supply pressure setting too high).

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16825720
• Report Number: 1823260-2023-01420
• Device Sequence Number: 6986942
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 06/29/2023

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: 09/30/2023
• Device Catalogue Number: 08057427190
• Device Lot Number: 645917
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/29/2023
• 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