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

Model Number B12 G2

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/23/2023

Event Type  malfunction  

Manufacturer Narrative

The quality control results were within range.The investigation is ongoing.

Event Description

There was an allegation of questionable vitamin b12 g2 elecsys results from cobas 6000 e601 module serial number: (b)(4).Sample 1 initial result was 75.0 pg/ml.The result from an advia analyzer was 179.0 pg/ml.Sample 2 initial result was 179.9 pg/ml.The result from an advia analyzer was 268 pg/ml.Sample 3 initial result was 195.1 pg/ml.The result from an advia analyzer was 272 pg/ml.Sample 4 initial result was 156.2 pg/ml.The result from an advia analyzer was 260 pg/ml.Sample 5 initial result was 104.9 pg/ml.The result from an advia analyzer was 264 pg/ml.Sample 6 initial result was 180.0 pg/ml.The result from an advia analyzer was 402 pg/ml.Sample 7 initial result was 129.2 pg/ml.The result from an advia analyzer was 392 pg/ml.Sample 8 initial result was 174.2 pg/ml.The result from an advia analyzer was 436 pg/ml.Sample 9 initial result was 213 pg/ml.The result from an advia analyzer was 740 pg/ml.The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.Medwatch field d4: expiration date was updated.

• 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: 16555876
• MDR Text Key: 312222088
• Report Number: 1823260-2023-00840
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 643757
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• 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