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

Catalog Number 09038086190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e801 analyzer is (b)(6).Medwatch field e1 facility name - (b)(6) hospital.Calibration and controls were acceptable.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for four patient samples tested with elecsys vitamin d total iii on a cobas e 801 module.The first sample initially resulted in a vitamin d value of 81.7 ng/ml and it repeated as 35.2 ng/ml.The second sample initially resulted in a vitamin d value of 104 ng/ml on (b)(6) 2024.The sample was repeated three times on (b)(6) 2024, resulting in values of 38.2 ng/ml, 98.5 ng/ml, and 95.9 ng/ml.The reagent pack was changed and the sample was repeated on (b)(6) 2024, resulting in a value of 25.4 ng/ml.The third sample initially resulted in a vitamin d value of 50.4 ng/ml on (b)(6) 2024.The sample was repeated on (b)(6) 2024, resulting in a value of 37.1 ng/ml.The reagent pack was changed and the sample was repeated on (b)(6) 2024, resulting in a value of 26.9 ng/ml.The fourth sample initially resulted in a vitamin d value of 105 ng/ml on (b)(6) 2024.The sample was repeated twice on (b)(6) 2024, resulting in values of 18 ng/ml and 28.0 ng/ml.The reagent pack was changed and the sample was repeated on (b)(6) 2024, resulting in a value of 27.9 ng/ml.The values measured after the reagent pack change were reported outside of the laboratory as these agreed with the previous values of the patients.

Manufacturer Narrative

Calibration and controls were acceptable prior to the event.A general reagent issue could be ruled out as controls were acceptable.Upon review of the alarm trace, no relevant alarms were observed.Analyzer performance testing was within specifications.The field service engineer checked the mixer and probe position; these were acceptable.Precision studies were acceptable.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18695350
• MDR Text Key: 336514402
• Report Number: 1823260-2024-00416
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): Y
• Reporter Country Code: TW
• 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: Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09038086190
• Device Lot Number: 744661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1