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

Model Number VITD TOTAL

Device Problem High Test Results (2457)

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

Event Date 12/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation reviewed the customer's qc results.The investigation confirmed there were imprecision and low recoveries with qc results between the end of (b)(6) 2021 and the beginning of (b)(6) 2022.The patient's sample was requested for an investigation, but the customer confirmed no sample was available.For dilution testing, product labeling states, "samples with vitamin d (25-oh) concentrations above the measuring range can be manually diluted with diluent universal or a suitable human serum with a low analyte concentration.The recommended dilution is 1:2.The concentration of the diluted sample must be >30.0 ng/ml (>75.0 nmol/l).After manual dilution, multiply the results by the dilution factor 2.The endogenous analyte concentration of the human serum used for dilution has to be taken into account." the investigation is ongoing.

Event Description

The initial reporter received questionable elecsys vitamin d assay results for one patient tested on a cobas e411 disk.Prior to patient testing, the customer confirmed qc was within the acceptable range.The patient's elecsys vitamin d result was reported outside the laboratory.The patient's physician questioned the reported result as it did not match the patient's history.The customer performed dilution testing and sent the sample to a different laboratory for testing on a vidas analyzer.The patient's initial elecsys vitamin d result was ">70" ng/ml.The patient's repeat elecsys vitamin d result with a 1:3 dilution was 145.6 ng/ml with a data flag.The customer's vitamin d result interpretation was "possible toxicity." the patient's vidas vitamin d result was 86.7 ng/ml.The customer's vitamin d result interpretation was sufficient.The e411 serial number was (b)(4).

Manufacturer Narrative

The investigation reviewed the provided sample pre-analytic details, and the number of tube inversions was insufficient compared to the manufacturer's recommendations, and the sample clotting time was requested but not provided.The investigation reviewed the provided alarm trace and found sample short alarms on (b)(6) 2022.The alarm trace from the date of the event were requested but not provided.Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D ASSAY
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13731427
• MDR Text Key: 293080132
• Report Number: 1823260-2022-00654
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K113546
• 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: 04/15/2022

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 Expiration Date: 09/30/2022
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 57362001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 04/15/2022
• 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: 68 YR
• Patient Sex: Female