MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALCIUM GEN. 2; TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM

Catalog Number	05061482190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's calibration and qc were acceptable.The field service representative checked all probe alignments (all probes were only less than 6 months old).He checked the rinse level and water pressure while running continuous mechanical checks, which were all acceptable.Preventive maintenance was completed and a precision test was performed.The syringe seals, diaphragms, heat cut filter, hepa filter, and rinse nozzle squeeges were replaced.The probes, rinse nozzles, rinse stations, splash shields, and covers were cleaned.All shafts and guide rail bearings were cleaned and lubricated.The cellwash solution was replaced.Mulitple air purges, cell detergent primes, incubation water exchange, a photometer check, cell blank measurement and mechanism checks were all performed.Qc and calibration was performed.He verified the precision test was in accordance with roche¿s precision guidelines.Qc was verified to be within range.The field service representative did not find a cause for the issue.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable calcium gen.2 results for 2 patient samples on a cobas 8000 c 502 module.Patient 1: the initial result was 5.6 mg/dl.The initial result was reported outside of the laboratory.The sample was repeated due to the initial result having a critical flag.The repeated result was 9.6 mg/dl.The repeated result was believed to be correct.Patient 2: the initial result was 6.1 mg/dl.The initial result was not reported outside of the laboratory.The repeated result was 9.9 mg/dl.The repeated results were obtained on another analyzer.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.

• Brand Name: CALCIUM GEN. 2
• Common Device Name: TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM
• 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: 19285123
• Report Number: 1823260-2024-01405
• Device Sequence Number: 18222916
• Product Code: CHW
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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): 06/14/2024

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: 05061482190
• Device Lot Number: 76942501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/14/2024
• 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