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

Catalog Number 07212771190

Device Problem High Test Results (2457)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

The initial reporter questioned high results for an unspecified number of patient samples tested for elecsys vitamin b12 ii (vitamin b12 ii) on a cobas e411 disk analyzer.Discrepant results were provided for 2 patient samples when compared to a competitor method.Patient 1: the initial result from the customer¿s e411 analyzer was 713 pg/ml.The repeat from an e411 analyzer used at the customer¿s sister laboratory was 699.4 pg/ml.The repeat result from the competitor method was 519 pg/ml.Patient 2: the initial result from the customer¿s e411 analyzer was 650 pg/ml.The repeat from an e411 analyzer used at the customer¿s sister laboratory was 591.1 pg/ml.The repeat result from the competitor method was 449 pg/ml.

Manufacturer Narrative

The customer¿s e411 analyzer serial number was (b)(4).The serial number for the e411 analyzer used at the sister laboratory was not provided.The competitor method was architect.

Manufacturer Narrative

Calibration data was within expectations.Qc data was within the specified ranges.The field application specialist (fas) checked the instrument alignments and pinch valve tubes.Based on the calibration and qc data, a general reagent issue is not suspected.The investigation did 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: 18028582
• MDR Text Key: 326833311
• Report Number: 1823260-2023-03459
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): Y
• Reporter Country Code: MU
• 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: 11/20/2023

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 Catalogue Number: 07212771190
• Device Lot Number: 728618
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/20/2023
• 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