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

Catalog Number 09038078190

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas 6000 e601 module is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys vitamin d assay results from five patient samples tested on the cobas 6000 e601 module.The reporter was able to provide the following examples of discrepant results: the initial results were not reported outside of the laboratory.Sample (b)(6).On (b)(6) 2023, the initial result was 3.00 ng/ml with a data flag.On (b)(6) 2023, the first repeat result was 3.00 ng/ml with a data flag.On (b)(6) 2023, the second repeat result was 13.44 ng/ml.This result was reported to the patient.Sample (b)(6).On (b)(6) 2023, the initial result was 3.00 ng/ml with a data flag.On (b)(6) 2023, the first repeat result was 3.00 ng/ml with a data flag.On (b)(6) 2023, the second repeat result was 13.42 ng/ml.This result was reported to the patient.Sample (b)(6): on (b)(6) 2023, the initial result was a data flag with no numerical result.On (b)(6) 2023, the first repeat result was 3.00 ng/ml with a data flag.On (b)(6) 2023, the second repeat result was 15.79 ng/ml this result was reported to the patient.Sample (b)(6).On (b)(6) 2023, the initial result was 80.06 ng/ml.On (b)(6) 2023, the first repeat result was 77.76 ng/ml.On (b)(6) 2023, the second repeat result was 44.65 ng/ml.This result was reported to the patient.

Manufacturer Narrative

The investigation reviewed the calibration data.The calibration signals of calibrator 1 were too low and out of specification; a calibration issue is possible.The investigation reviewed the qc data; the qc was out of range on the day of event.In the qc history, qc level 1 was unusually low before the patient sample run but after a new calibration, no new qc runs were performed.For qc level 2, the result was higher on (b)(6) 2023 at 11:43 am; but there was no new qc result available after recalibration on (b)(6) 2023 at 12:08 pm.The qc was conspicuous as well.The investigation reviewed the customer's handling of patient samples.The patient sample was inverted 2-3 times; the investigation determined that the number of inversions was too low as at least 8-10 x 180° inversions are recommended.The serum coagulation time was 15 minutes; the investigation determined that the coagulation time was too short as more than 30 minutes is recommended.The investigation reviewed the alarm trace; the trace had repeatedly "abnormal sample aspiration" alarms which may indicate sample quality issues.The investigation determined there was no indication of a reagent issue.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: 18455785
• MDR Text Key: 332731112
• Report Number: 1823260-2024-00051
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): Y
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09038078190
• Device Lot Number: 74343100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• 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