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 04/16/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with the elecsys vitamin d total gen.3 assay on a cobas 6000 e 601 module.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The samples were initially tested on 16-apr-2022 and repeated with dilution.A new reagent pack was placed on board on 17-apr-2022 and control recovery was not good.Calibration signals from the last calibration performed on 13-apr-2022 were higher than expected, so the assay was recalibrated on 19-apr-2022 and the samples were repeated.The first sample initially resulted in a vitamin d value of > 120 ng/ml.The sample was diluted "1/2" and repeated, resulting in a value of 83.1 ng/ml.After recalibration, the sample was repeated on 19-apr-2022, resulting in a value of 29.15 ng/ml.The second sample initially resulted in a vitamin d value of > 120 ng/ml.The sample was diluted "1/2" and repeated, resulting in a value of 51.26 ng/ml.After recalibration, the sample was repeated on 19-apr-2022, resulting in a value of 16.56 ng/ml.The third sample initially resulted in a vitamin d value of > 120 ng/ml.The sample was diluted "1/2" and repeated, resulting in a value of 60.82 ng/ml.After recalibration, the sample was repeated on 19-apr-2022, resulting in a value of 61.60 ng/ml.The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

The initial values were reported outside of the laboratory.The physicians did not agree with the results since they did not agree with the clinical status of the patients.

Manufacturer Narrative

A difference between calibrations performed on (b)(6) 2022 and (b)(6) 2022 could be observed.Each calibration was performed on a different reagent pack.For the calibration performed on (b)(6) 2022 with the first reagent pack, the first level calibrator signals were higher than expected and the second level recovered within expectations.For the calibration performed on (b)(6) 2022 with the second reagent pack, the first level calibrator signals were borderline lower than expected and the second level recovered within expectations.For the first reagent pack, data for only one level of control was provided.Most values were within range, but three values were outside of the second standard deviation range.Measurements performed on (b)(6) 2022 were within range.For the second reagent pack, data for only one level of control was provided.Most values were within range, but two values were outside of the second standard deviation range.A measurement performed on (b)(6) 2022 was within range.Additional quality control data was provided for two levels of control, but it was not clear which reagent pack this was performed on.These controls were within range on (b)(6) 2022 and (b)(6) 2022.The investigation could not identify a product problem.The cause of the event could not be determined.A general reagent issue could be excluded.Updated medwatch field: d4 - expiration date.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14286168
• MDR Text Key: 294037643
• Report Number: 1823260-2022-01277
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 09038078190
• Device Lot Number: 580055
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• 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