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

Model Number VITD TOTAL

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

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

Event Date 04/19/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable vitamin d total elecsys results from cobas e411 rack serial number (b)(4).Patient 125178448 initial result was > 70 ng/ml with a data flag and the repeat results were 31.94 ng/ml and 32.14 ng/ml.With a dilution, the repeat result was 16.89 ng/ml.Patient 125173235 initial result was > 70 ng/ml with a data flag and the repeat results were 36.27 ng/ml and 36.32 ng/ml.With a dilution, the repeat result was 18.36 ng/ml.On (b)(6) 2022, patient 125340315 initial result was > 70 ng/ml with a data flag and the repeat result was 27.34 ng/ml.On (b)(6) 2022, the repeat result was 26.87 ng/ml and with a dilution, the repeat result was 11.53 ng/ml.Patient 125333583 initial result was > 70 ng/ml with a data flag and the repeat results were 32.36 ng/ml and 30.80 ng/ml.With a dilution, the repeat result was 14.09 ng/ml.Patient 125349861 initial result > 70 ng/ml with a data flag.The repeat result was 24.37 ng/ml.With a dilution, the repeat result was 11.43 ng/ml.On (b)(6) 2022, the repeat result was 24.42 ng/ml.The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

Based on the available data, a clear root cause could not be identified.As the issue occurred during a defined time frame and on the same reagent kits, a temporary reagent issue such as bubbles or foam on the reagent was possible.There was no evidence of a general reagent issue.The investigation is ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL
• 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: 14402196
• MDR Text Key: 300144393
• Report Number: 1823260-2022-01395
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 58937300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• 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: 44 YR
• Patient Sex: Female