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

Catalog Number 07464215160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the elecsys vitamin d total gen.2 assay on a cobas 6000 e 601 module.No incorrect results were reported outside of the laboratory.The samples were repeated and the repeat results were believed to be correct.The first sample initially resulted with a vitamin d value of > 100 ng/ml accompanied by a data flag.The sample was repeated, resulting with a value of 34.48 ng/ml.The second sample initially resulted with a vitamin d value of > 100 ng/ml accompanied by a data flag on 22-oct-2020.The sample was repeated, resulting with a value of 63.48 ng/ml.The e 601 analyzer serial number is (b)(4).

Manufacturer Narrative

The field service engineer checked water pressure, gear pump pressure, and all probe alignments.Mixer alignments were performed.Controls were tested and the analyzer was determined to be operating within specifications.The last calibration performed on (b)(6) 2020 was ok, with no alarms.Quality controls were within range, showing no indication of a reagent performance issue.Sample centrifugation time was higher than recommended by the tube manufacturer.The samples were plasma and were not aliquoted into a secondary tube prior to measurement.Product labeling states: "re-centrifuge plasma samples in a secondary tube for 10 min at 2000 x g prior to measurement." the investigation determined the issue was related to incorrect pre-analytic sample handling.

• Brand Name: ELECSYS VITAMIN D TOTAL II
• Type of Device: VITAMIN D TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10843274
• MDR Text Key: 216379252
• Report Number: 1823260-2020-02903
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• PMA/PMN Number: K162840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 07464215160
• Device Lot Number: 48469401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN CODEINE (PATIENT 2); ARMOR THYROID (PATIENT 1); ARMOR THYROID (PATIENT 2); ASPIRIN (PATIENT 1); CALCIUM (PATIENT 1); ELIQUIS (PATIENT 2); LOSARTAN POTASSIUM (PATIENT 2); MULTIVITAMIN (PATIENT 1); PREDNISONE (PATIENT 2); PROTONIX (PATIENT 2); TIMOLOL MALEATE (PATIENT 2); VITAMIN B12 (PATIENT 2); VITAMIN D (PATIENT 2); ZOLOFT (PATIENT 2); ACETAMINOPHEN CODEINE (PATIENT 2); ARMOR THYROID (PATIENT 1); ARMOR THYROID (PATIENT 2); ASPIRIN (PATIENT 1); CALCIUM (PATIENT 1); ELIQUIS (PATIENT 2); LOSARTAN POTASSIUM (PATIENT 2); MULTIVITAMIN (PATIENT 1); PREDNISONE (PATIENT 2); PROTONIX (PATIENT 2); TIMOLOL MALEATE (PATIENT 2); VITAMIN B12 (PATIENT 2); VITAMIN D (PATIENT 2); ZOLOFT (PATIENT 2)
• Patient Age: 67 YR