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

Catalog Number 07028121214

Device Problems Mechanical Problem (1384); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

The e801 analyzer serial number is (b)(6).The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys vitamin b12 ii on a cobas e 801 analytical unit.The sample initially resulted in a vitamin b12 value of 168 pg/ml.A doctor questioned the initial value, so the sample was repeated.The repeat result was > 2000 pg/ml and was deemed correct.

Manufacturer Narrative

The last calibration was performed on (b)(6) 2023.Per product labeling, renewed calibration is recommended: after 12 weeks when using the same reagent lot.After 28 days when using the same cobas e pack on the analyzer.As required: e.G.Quality control findings outside the defined limits.Quality controls recovered within range.There was no indication of a reagent or instrument performance issue.The field service engineer confirmed that analyzer adjustments, wash levels, and pressures were within specifications.Instrument checks were performed and were acceptable.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18591793
• MDR Text Key: 334027970
• Report Number: 1823260-2024-00240
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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 Catalogue Number: 07028121214
• Device Lot Number: 711483
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/06/2024
• 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
• Patient Age: 52 YR
• Patient Sex: Male