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

Catalog Number	07028148190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the elecsys vitamin d total gen.2 assay (vitd2) on a cobas 8000 e 801 module.The customer was performing a method comparison study between the vitd2 assay and the elecsys vitamin d total gen.3 assay (vitd3) and values measured with two patient samples did not agree.Only the values from the vitd2 assay were reported outside of the laboratory.The customer did not know which values were correct.The primary tube of the first sample resulted in a vitd2 value of 114 ng/ml and a vitd3 value of 28.9 ng/ml.The secondary tube of the firs sample resulted in a vitd2 value of 109 ng/ml and a vitd3 value of 30.5 ng/ml.The second patient sample was diluted prior to measurement.The primary tube of the second sample resulted in a vitd2 value of 142 ng/ml and a vitd3 value of 18.3 ng/ml.The secondary tube of the second sample resulted in a vitd2 value of 137 ng/ml and a vitd3 value of 19.3 ng/ml.The serial number of the e 801 analyzer is (b)(4).
Additional Manufacturer Narrative
The complained patient samples were provided for investigation and the customer's results could be reproduced.
Additional Manufacturer Narrative
The expiration date for vitd2 reagent lot 570755 is august 2022.The last vitd2 calibration was performed on (b)(6) 2022.The first calibrator level signals were lower than expected.Vitd2 quality control data from (b)(6) 2022 to (b)(6) 2022 was within range.Upon review of alarm trace data from (b)(6) 2022 to (b)(6) 2022, there were 28 sample short alarms and 8 sample clot detection alarms.Upon further investigation of the provided patient samples, it was determined through hplc-ms/ms testing that the sample contained biotin levels significantly above the claimed biotin threshold for the vitd2 assay.The sample from patient 1 was found to contain 216.06 ng/ml of biotin and the sample from patient 2 was found to contain 254.57 ng/ml of biotin.Per product labeling for vitd2: "highest concentration of substance tested that demonstrated no significant interference: biotin = = 123 nmol/l or = 30 ng/ml".

• Brand Name: ELECSYS VITAMIN D TOTAL II
• Common Device Name: 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15183880
• Report Number: 1823260-2022-02348
• Device Sequence Number: 6389830
• Product Code: MRG
• UDI-Device Identifier: 04015630940127
• UDI-Public: 04015630940127
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07028148190
• Device Lot Number: 570755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 09/07/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/02/2022; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown