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

Catalog Number 07028148190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The patient sample was submitted for investigation where the customer's results were reproduced (147 ng/ml).A general reagent issue has been excluded.Investigations are ongoing.

Event Description

The initial reporter complained of high results that did not fit the clinical picture for 1 oncology patient receiving chemotherapy tested for elecsys vitamin d total ii (vitamin d ii) on a cobas e801 module.The initial result was > 100 ng/ml with a data flag.The repeat result was > 100 ng/ml with a data flag.The customer manually diluted the sample 1:1 and repeated with results of 67.2 ng/ml with a data flag (calculated result 134.4 ng/ml) and 65.4 ng/ml with a data flag (calculated result 130.8 ng/ml).On (b)(6) 2019 a new sample was obtained and the initial result was > 100 ng/ml with a data flag.The repeat result was > 100 ng/ml with a data flag.The customer manually diluted the sample 1:1 and repeated with results of 63.9 ng/ml with a data flag (calculated result 127.8 ng/ml) and 64.5 ng/ml with a data flag (calculated result 129 ng/ml).The high results were reported outside of the laboratory where they were questioned.There was no allegation that an adverse event occurred due to the device results.The e801 module serial number was (b)(4).

Manufacturer Narrative

The customer¿s high result was confirmed by the lc-ms/ms method.The vit d total ii results are considered correct.A product problem was not identified.

• 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: 8707401
• MDR Text Key: 148309580
• Report Number: 1823260-2019-02230
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

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 Catalogue Number: 07028148190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PEMETREXED; PEMETREXED