MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN B12 II; RADIOASSAY, VITAMIN B12

Model Number B12 G2

Device Problems Imprecision (1307); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys vitamin b12 ii on a cobas e411 disk.No questionable results were reported outside of the laboratory.The customer loaded a new vitamin b12 reagent pack on the instrument and performed a calibration.The control recovered 2 standard deviations lower than the mean.The patient sample was then initially tested and resulted in a vitamin b12 value of 178.5 pg/ml.The customer then re-calibrated the vitamin b12 reagent with new calibrator material and the control recovered 2 standard deviations above the mean.The patient sample was then repeated, resulting in a vitamin b12 value of 328.1 pg/ml.

Manufacturer Narrative

The serial number of the e411 analyzer is (b)(6).The investigation is ongoing.H3 other text : na.

Manufacturer Narrative

The investigation was unable to determine a specific root cause.As the issue improved after a new calibrator aliquot was used, the issue is consistent with calibrator handling and/or storage issues.No general reagent issue was found.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• 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: 17308901
• MDR Text Key: 319470215
• Report Number: 1823260-2023-02224
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K060755
• 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: 08/22/2023

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
• Device Operator: Health Professional
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 70733100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/22/2023
• 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