MAUDE Adverse Event Report: 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 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas c 303 analytical unit serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable magnesium (mg2) results from the cobas c 303 analytical unit.The initial result was 2.8 mg/dl.The doctor questioned the result and the sample was repeated with a result of 2.1 mg/dl.The repeat result was deemed correct.

Manufacturer Narrative

The field service engineer found there was a low rinse volume on the reagent probe.He ran precision testing and noticed the customer was using a different lot number of calibration material than what was programmed in the system.He checked the pump pressure and gear pump pressure which were within specifications.He cleaned a solenoid valve and a valve for the reagent probe rinse.He adjusted the probe rinse, cleaned the probe, and confirmed the rinse mechanism levels were within specifications.He recalibrated and ran qc which passed.He ran a carryover check which passed.The investigation determined the service actions resolved the issue.Medwatch fields d1-d4, g1, and g4 were 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18456190
• MDR Text Key: 332208444
• Report Number: 1823260-2024-00057
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K220134
• 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: 01/31/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 70737801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• 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: 79 YR
• Patient Sex: Male