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 12/17/2023

Event Type  malfunction  

Manufacturer Narrative

The c303 analyzer serial number was (b)(6).The field service engineer (fse) replaced and adjusted the reagent probe.The investigation is ongoing.

Event Description

The initial reporter complained of a discrepant high result for 1 patient sample tested for magnesium reagent (mg2) on a cobas c 303 analytical unit.The initial result was 2.98 mg/dl.This result was reported outside of the laboratory where it was questioned by the doctor.The sample was repeated with a result of 2.28 mg/dl.This result was believed to be correct.

Manufacturer Narrative

Section d, device identification was updated.Relevant fields of sections d and g were updated.The mg2 reagent lot number was 73167701 with an expiration date of (b)(6) 2025.The customer used a centrifugation time of 3 minutes at 8000 revolutions per minute (rpm).Based on the type of sample tubes used, the centrifugation speed should be at or less than 1300g for 10 minutes.Calibration was acceptable.The service actions (replacing and adjusting the reagent probe) resolved the issue.

• 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: 18465288
• MDR Text Key: 332974922
• Report Number: 1823260-2024-00074
• 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: 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: 02/26/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1