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

Catalog Number 08058016190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's (b)(6) analyzer is (b)(6).The investigation is ongoing.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 334626788
• Report Number: 1823260-2024-00298
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 07613336121412
• UDI-Public: 07613336121412
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K983416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08058016190
• Device Lot Number: 73167701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male