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

Catalog Number 08058016190

Device Problem 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 cobas c 303 analyzer is (b)(6).The field service engineer could not determine a cause.The main supply pump pressure was adjusted.The gear pump was adjusted.The sample and reagent probe wash levels were adjusted.The rinse mechanism adjustment was verified.Cuvette detergent wash, rinse, and blank cell levels were within specifications.The reagent probe was replaced and adjusted.A degasser water trap drain on the sample supply unit was observed to be cracked.Precision studies were performed and recovered lower than the guidelines.The investigation is ongoing.

Event Description

The customer stated they have been having issues with quality control recovery for the magnesium reagent on a cobas c 303 analytical unit.The control recovery will initially be high and will be within range when repeated.The customer also provided examples of 3 patient samples with discrepant magneisum results.The initial values for these samples were considered correct.The samples were repeated to troubleshoot the control issue.The first sample initially resulted in a magnesium value of (b)(6) when tested on the complained analyzer on (b)(6) 2023.The sample was repeated twice on the complained analyzer on (b)(6) 2023, resulting in values of (b)(6).The second sample initially resulted in a magnesium value of (b)(6) when tested on a second analyzer on (b)(6) 2023.The sample was repeated on the complained analyzer, resulting in a value of (b)(6) on (b)(6) 2023.The third sample initially resulted in a magnesium value of (b)(6) when tested on the complained analyzer on (b)(6) 2023.The sample was repeated three additional times on the complained analyzer on (b)(6) 2023, resulting in values of (b)(6).

Manufacturer Narrative

The last calibration performed on 05-dec-2023 was ok and there were no alarms.Quality controls recovered within range.There was no indication of an instrument or reagent performance issue.The field service engineer returned and replaced the cracked degasser water trap drain valve.The engineer verified probe adjustments and programmed additional carryover wash cycles on the instrument.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1-d4, g1, and g4 have been updated.

• Brand Name: 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: 18516840
• MDR Text Key: 333016881
• Report Number: 1823260-2024-00143
• 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
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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: 12/28/2023
• 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