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

Catalog Number 07212771190

Device Problems High Test Results (2457); Material Integrity Problem (2978)

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas e411 disk is (b)(6).The reporter stated that they speculated that the reagent did not require calibration; they then ran the qcs and patient samples.The analyzer date is backdated.The patient sample was requested for investigation.The investigation reviewed the last calibration performed on 01-apr-2023; the results were within specifications.The investigation noted that the last calibration was 9 months before the date of event.Product labeling states "calibration frequency: calibration must be performed once per reagent lot using fresh reagent (i.E.Not more than 24 hours since the reagent kit was registered on the analyzer).Calibration interval may be extended based on acceptable verification of calibration by the laboratory.Renewed calibration is recommended as follows: ¿ after 1 month (28 days) when using the same reagent lot ¿ after 7 days (when using the same reagent kit on the analyzer) ¿ as required: e.G.Quality control findings outside the defined limits." the investigation reviewed the last qc data dated 07-aug-2023; the qc results were within specifications.The investigation noted that the last qc was 5 months before the date of event.Product labeling states "quality control use elecsys precicontrol varia or other suitable controls for routine quality control procedures.Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration." the investigation is ongoing.

Event Description

The initial reporter received questionable elecsys vitamin b12 immunoassay results from an unspecified number of patient samples tested on the cobas e411 disk.The reporter stated that they have been obtaining discrepant vitamin b12 patient results from the analyzer within the last two weeks.The reporter was able to provide one example of discrepant results: the initial result from the analyzer was 809.3 pg/ml.The repeat result from an outside laboratory that uses a "taurus" system was 519 pg/ml.

Manufacturer Narrative

The patient sample was not received for investigation.The investigation reviewed the customer's handling of patient samples; the customer used a fixed centrifuge that can lead to a build-up of slant sediments and is therefore not recommended by most tube manufacturers.Based on the information provided, the investigation did not identify a product problem.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: 18639049
• MDR Text Key: 334501377
• Report Number: 1823260-2024-00316
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): Y
• Reporter Country Code: LE
• 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: 03/13/2024

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: 07212771190
• Device Lot Number: 728618
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/13/2024
• 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
• Patient Age: 30 YR
• Patient Sex: Male