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

Catalog Number 09038078190

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

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

The e601 module serial number was (b)(6).Calibration failed on (b)(6) 2023.The most recent valid calibration was performed on (b)(6) 2023 with signals lower than expected.Qc was acceptable.The customer inverted the sample tube 5 times; this is too few tube inversions.The customer used a clotting time of 10 minutes; the clotting time should be a minimum of 30 minutes."abnormal sample aspiration" and "reagent warning level" alarms were observed on the alarm trace data.The investigation is ongoing.

Event Description

The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys vitamin d total iii (vitamin d total iii) on a cobas 6000 e 601 module.The initial result was > 120.0 ng/ml with a data flag.The repeat result using a 1:2 dilution was 15.6 ng/ml.The sample was repeated with no dilution and the result was 26.20 ng/ml.The questionable high result was not reported outside of the laboratory.

Manufacturer Narrative

Based on the information provided, the cause of the event could not be determined.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17145444
• MDR Text Key: 317765856
• Report Number: 1823260-2023-02004
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 08/14/2023

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: 11/30/2023
• Device Catalogue Number: 09038078190
• Device Lot Number: 70128702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/14/2023
• 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
• Patient Sex: Male