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

Catalog Number 07212771190

Device Problem Non Reproducible Results (4029)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys vitamin b12 ii (b12 ii) on a cobas e411 disk analyzer.After the initial point of contact, additional data was provided.Of the data provided, discrepant results were identified for 6 additional patient samples tested on both of the customer¿s e411 analyzers (analyzer 1 and analyzer 2).The following results were obtained from analyzer 1: on (b)(6) 2024 patient 1 initial result was 115.2 pg/ml.The repeat result was 288.4 pg/ml.Patient 2 initial result was 167.4 pg/ml.The repeat result was 355.3 pg/ml.On (b)(6) 2024 patient 3 initial result was 140.0 pg/ml.The repeat result was 248.0 pg/ml.On (b)(6) 2024 patient 4 initial result was 242.2 pg/ml.The repeat result was 178.9 pg/ml.On (b)(6) 2024 patient 5 initial result was 142.3 pg/ml.The repeat result was 224.2 pg/ml.On (b)(6) 2024 patient 6 initial result was 147.5 pg/ml.The repeat result was 212.0 pg/ml.The following results were obtained from analyzer 2: on (b)(6) 2024 patient 7 initial result was 145.2 pg/ml.The sample was repeated twice with results of 192.8 pg/ml and 144.6 pg/ml.

Manufacturer Narrative

Analyzer 1 serial number is (b)(6).Analyzer 2 serial number is (b)(6).

Manufacturer Narrative

Discrepant vitamin b12 ii results were provided for an additional patient sample tested on (b)(6) 2024 on analyzer 1: the initial result was 155.6 pg/ml.The sample was repeated twice with results of 202.8 pg/ml and 176.5 pg/ml.

Manufacturer Narrative

Discrepant vitamin b12 ii results were provided for 3 additional patient samples tested on analyzer 1: sample id (b)(6) : on (b)(6) 2024 the initial result was 173.4 pg/ml.The repeat result was 254.8 pg/ml.Sample id (b)(6) : on (b)(6) 2024 the initial result was 219.2 pg/ml.The repeat result was 130.8 pg/ml.Sample id (b)(6) : on (b)(6) 2024 the initial result was < 50.00 pg/ml with a data flag.The sample was repeated twice with results of 1081 pg/ml and 990.6 pg/ml.For analyzer 1: calibration and qc were acceptable.Preventive maintenance was last performed on (b)(6) 2024; the measuring cell was replaced at that time.Instrument performance testing was acceptable.No issues were identified during a review of the alarm trace data.For analyzer 2: calibration and qc were acceptable.Extensive troubleshooting was performed related to the instrument, reagent handling, and pre-analytical handling; a specific cause was not found.The calibration and qc data for both instruments do not suggest a general reagent issue.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: 19089854
• MDR Text Key: 339984832
• Report Number: 1823260-2024-01128
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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: 05/02/2024

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: 07212771190
• Device Lot Number: 707331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/02/2024
• 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