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

Catalog Number 07464215160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/05/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable vitamin d total g2 elecsys and vitamin d total g3 elecsys results for 14 patient samples tested on the cobas 6000 e601 module with serial number (b)(4).The reporter is questioning vitamin d v3 results compared to vitamin d v2 patient results.The initial results were reported outside of the laboratory.The samples of patients 27, 29, 35 and 37 were rerun on the module and a siemen's intellica.Patient 4 had an initial vitamin d v3 result of >120 ng/ml with a data flag.The vitamin d v2 repeat result was 77.6 ng/ml.Patient 5 had an initial vitamin d v3 result of 76 ng/ml.The vitamin d v2 repeat result was 48.5 ng/ml.Patient 10 had an initial vitamin d v3 result of 91.8 ng/ml.The vitamin d v2 repeat result was 51.8 ng/ml.Patient 13 had an initial vitamin d v3 result of >120 ng/ml with a data flag.The vitamin d v2 repeat result was 76.2 ng/ml.Patient 16 had an initial vitamin d v3 result of 62.7 ng/ml.The vitamin d v2 repeat result was 40.6 ng/ml.Patient 22 had an initial vitamin d v3 result of 67.2 ng/ml.The vitamin d v2 repeat result was 34.1 ng/ml.Patient 27 had an initial vitamin d v3 result of 117.7 ng/ml.The vitamin d v2 first repeat result from the module was 74.1 ng/ml.The second repeat result from the siemens intellica is 67.65 ng/ml.Patient 29 had an initial vitamin d v3 result of 107.3 ng/ml.The vitamin d v2 first repeat result from the module was 70.7 ng/ml.The second repeat result from the siemens intellica is 62.27 ng/ml.Patient 31 had an initial vitamin d v3 result of 115.9 ng/ml.The vitamin d v2 first repeat result was 74.8 ng/ml.Patient 32 had an initial vitamin d v3 result of 78.5 ng/ml.The vitamin d v2 first repeat result was 45.5 ng/ml.Patient 34 had an initial vitamin d v3 result of 72 ng/ml.The vitamin d v2 first repeat result was 43.9 ng/ml.Patient 35 had an initial vitamin d v3 result of 17.4 ng/ml.The vitamin d v2 first repeat result from the module was 39.5 ng/ml.The second repeat result from the siemens intellica is 15.58 ng/ml.Patient 36 had an initial vitamin d v3 result of >120 ng/ml with a data flag.The vitamin d v2 first repeat result was 75.6 ng/ml.Patient 37 had an initial vitamin d v3 result of 80.1 ng/ml.The vitamin d v2 first repeat result from the module was 54.72 ng/ml.The second repeat result from the siemens intellica is 15.58 ng/ml.No result was deemed correct.The vitamin d v3 reagent lot number is 622309 with an expiration date of dec-2022.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The field application specialist (fas) inspected the instrument.The fas ordered reagents and performed a 40-sample method comparison to ensure that the current and updated vitamin d assays correlated.The method comparison study was within specifications.The investigation determined the service actions resolved the issue.  the investigation determined that the product performance was within specifications.

• 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
• 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: 15266742
• MDR Text Key: 305154549
• Report Number: 1823260-2022-02518
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 07613336129197
• UDI-Public: 07613336129197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 07464215160
• Device Lot Number: 602095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• 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