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

Catalog Number 09038078190

Device Problems High Test Results (2457); Insufficient Information (3190); Non Reproducible Results (4029)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas 8000 - cobas e 602 module is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys vitamin d assay results from three patient samples tested on the cobas 8000 - cobas e 602 module.The initial result was reported outside of the laboratory because the results did not match the patient's clinical diagnosis alerting the reporter to an issue with the results.Sample 1 the initial result was >70.00 ng/ml with a data flag.The repeat result was 40.43 ng/ml.Sample 2 the initial result was 50.08 ng/ml.The repeat result was 23.08 ng/ml.Sample 3 the initial result was 35.6 ng/ml.The repeat result was 14.43 ng/ml.

Manufacturer Narrative

The investigation reviewed the calibration data; the results were within specifications.The investigation reviewed the qc data; the qc was out of specified ranges (>+3 standard deviations-sd) before the patient sample was run.Product labeling states "the control intervals and limits should be adapted to each laboratory¿s individual requirements.Values obtained should all within the defined limits.Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.If necessary, repeat the measurement of the samples concerned." the investigation reviewed the alarm trace; the trace had one "sample short" (b)(6)2023, 11:39:05); two "abnormal sample aspiration" ((b)(6)2023, 8:59:45 am and 08:11:49 am); and one "sample clot detection" ((b)(6)2023, t08:10:52) alarms.The customer did not use rack adapters used for the 13 mm primary tube.Product labeling states "warning! incorrect results may occur if tubes are not aligned vertically incorrect placement of tubes on racks may cause incorrect pipetting, which may lead to false results.Ensure that tubes and cups are always placed vertically and are inserted fully in the racks.Use the cup adapter for tubes with an outer diameter of 13 mm or less.Alternatively, use racks without stabilizers for 13 mm tubes." based on the provided data, a general reagent issue can most likely be excluded; another reagent kit of the same lot performed according to specifications at this customer site.The investigation determined the event was caused by the customer's failure to follow instructions when patient samples were run despite the qc being out of the specified ranges.The investigation did not identify a product problem.

• 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: 18226632
• MDR Text Key: 329237149
• Report Number: 1823260-2023-03783
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09038078190
• Device Lot Number: 733368
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• 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