MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL III; VITAMIN D TEST SYSTEM

Catalog Number 09038086190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

We received an allegation about 3 patients' samples tested with elecsys vitamin d total assay on a cobas pure analyzer when compared to a cobas e411 immunoassay analyzer.Sample 1: initial result: 22.88 nmol/l.Repeat result: 14.9 nmol/l (tested on e411).Sample 2: initial result: 36.18 nmol/l.Repeat result: 24 nmol/l (tested on e411).Sample 3: initial result: 33.5 nmol/l.Repeat result: 22.3 nmol/l (tested on e411).The initial results were obtained from a cobas pure analyzer.The customer mentioned that they received a negative bias in the proficiency survey sample results.The field service team then performed a sample comparison with e411 as part of the corrective action.The repeat results were deemed to be correct.

Manufacturer Narrative

On the day of the event, the alarm trace showed a couple of abnormal aspiration (sample pipetter) alarms, a couple of reagent below warning level alarms, and a qc result out of range alarm.The investigation is ongoing.

Manufacturer Narrative

The e411 calibration signals were lower than expected.It was also determined that the customer is using slightly different target values than what is required.Calibration signals were within expectations on the cobas pure analyzer.The provided quality control results were within specified ranges.Based on the provided data, a general reagent issue can be excluded.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• Type of Device: VITAMIN D TEST SYSTEM
• 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: 18661113
• MDR Text Key: 334786554
• Report Number: 1823260-2024-00361
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): Y
• Reporter Country Code: IZ
• PMA/PMN Number: K210901
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 09038086190
• Device Lot Number: 718894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• 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