MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN B12 II; RADIOASSAY, VITAMIN B12

Catalog Number 07028121190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

The vitamin b12 ii reagent expiration date was not provided.The cobas pure sample supply unit serial number was (b)(4).Qc was within the ranges.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's serum/plasma sample tested with elecsys vitamin b12 g2 (vitamin b12 ii) assay on a cobas pure sample supply unit.Initial result: 107 pg/ml.No questionable result was reported outside the laboratory as the customer noticed that the result did not match the patient's previous results.The sample was then repeated.Repeat result: 318 pg/ml.

Manufacturer Narrative

Section d4 was updated.Correction: from cobas pure sample supply unit to cobas e402 immunoassay analyzer.The sample was tested on a cobas e402 serial number (b)(6).The calibration was last performed 11 weeks before the day of the event and it was acceptable.The alarm trace and the pre-analytical data did not show any abnormality.A general reagent problem can be excluded because the qc prior to the event was within range.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• 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: 18537914
• MDR Text Key: 333168112
• Report Number: 1823260-2024-00173
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 07028121190
• Device Lot Number: 740845
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/16/2024
• 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