MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS MAGNESIUM REAGENT; PHOTOMETRIC MAGNESIUM ASSAY

Catalog Number	08058016190
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	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's (b)(6) analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The customer alleged they received discrepant results for two patient samples tested with the magnesium reagent on a cobas c 303 analytical unit.The initial values were reportedly questioned by the customer and the samples were repeated.The repeat values were deemed correct by the customer.The first sample reportedly resulted in an initial magnesium value of 2.0 mg/dl and it repeated as 1.1 mg/dl.The second sample reportedly resulted in an initial magnesium value of 2.6 mg/dl and it repeated as 1.8 mg/dl.
Additional Manufacturer Narrative
The field service engineer could not determine a cause.The engineer programmed carryover evasion washes on the analyzer for magnesium testing.Instrument checks passed.Precision studies were performed.No further issues occurred.Calibration data was acceptable.Quality controls recovered within established ranges.There was no indication of a reagent or instrument performance issue.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ROCHE DIAGNOSTICS MAGNESIUM REAGENT
• Common Device Name: PHOTOMETRIC MAGNESIUM ASSAY
• 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: 18627451
• Report Number: 1823260-2024-00298
• Device Sequence Number: 8067158
• Product Code: JGJ
• UDI-Device Identifier: 07613336121412
• UDI-Public: 07613336121412
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K983416
• 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): 02/02/2024

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: 08058016190
• Device Lot Number: 73167701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/02/2024
• 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: 73 YR
• Patient Sex: Male