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

Catalog Number	09038078160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated that starting (b)(6) 2023 they received questionable results for an unspecified number of patient samples tested with the elecsys vitamin d total iii on a cobas 6000 e601 module, serial number (b)(6).The reporter also mentioned quality control issues.Of the data provided, four patient samples received discrepant results with elecsys vitamin d total iii assay: patient sample 1: the sample initially resulted in a vitamin d total iii value of 45.8 ng/ml and repeated as 29.4 ng/ml.Patient sample 2: the sample initially resulted in a vitamin d total iii value of 61.7 ng/ml and repeated as 35.6 ng/ml.Patient sample 3: the sample initially resulted in a vitamin d total iii value of 44.8 ng/ml and repeated as 28.9 ng/ml.Patient sample 4: the sample initially resulted in a vitamin d total iii value of > 120 ng/ml accompanied by a data flag and repeated as 53.3 ng/ml.The repeat results were deemed correct.The questionable results of patient samples 1, 2, and 3 were reported outside of the laboratory and an amended report was issued.The questionable result of patient sample 4 was not reported outside of the laboratory.
Additional Manufacturer Narrative
The calibration performed on (b)(6) 2023 was acceptable with no alarms.On (b)(6) 2023 the customer recalibrated the affected reagent pack twice and the calibration signals shifted higher.The customer replaced the reagent pack and recalibrated twice, with the first calibration's signals matching their initial pack, and the second calibration receiving much higher signals.On (b)(6) 2023 the customer used a new reagent pack and recalibrated it with freshly made calibrators.The calibration was successful with no alarms.On (b)(6) 2023 the quality controls were successful with no alarms.On (b)(6) 2023 the quality controls were partially out of range.On (b)(6) 2023, quality controls were successfully performed on the new reagent pack with no alarms.Upon review of the alarm trace, abnormal probe-sucking errors were observed.These alarms are indicators of possible poor sample quality.After changing the reagent pack and performing a new calibration, the issue did not re-occur.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• Common Device Name: VITAMIN D ASSAY
• 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: 16919265
• Report Number: 1823260-2023-01613
• Device Sequence Number: 6910777
• Product Code: MRG
• UDI-Device Identifier: 07613336184615
• UDI-Public: 07613336184615
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 09038078160
• Device Lot Number: 66279701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male