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

Model Number B12 G2

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

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

The customer was also having qc issues with vitamin b12 ii reagent packs.Liquid flow cleaning was performed on (b)(6) 2023.Pinch tubes were replaced on (b)(6) 2023.The investigation is ongoing.

Event Description

The initial reporter questioned low results for 11 patient samples tested for elecsys vitamin b12 ii (vitamin b12 ii) on a cobas 6000 e 601 module.Of the data provided, the results for 9 patient samples were discrepant.Patient 1 initial result was 209.6 pg/ml.The sample was repeated twice with results of 320.2 pg/ml and 325.8 pg/ml.Patient 2 initial result was 366.2 pg/ml.The sample was repeated twice with results of 482.9 pg/ml and 503.9 pg/ml."patient 5" initial result was 261.1 pg/ml.The sample was repeated twice with results of 371.4 pg/ml and 391.9 pg/ml."patient 6" initial result was 341.1 pg/ml.The sample was repeated twice with results of 478.9 pg/ml and 495.2 pg/ml."patient 7" initial result was 283.3 pg/ml.The sample was repeated twice with results of 400.3 pg/ml and 413.5 pg/ml."patient 8" initial result was 201.2 pg/ml.The repeat result was 340.7 pg/ml."patient 9" initial result was 462.6 pg/ml.The sample was repeated twice with results of 597.4 pg/ml and 627.5 pg/ml."patient 10" initial result was 100.7 pg/ml.The repeat result was 210.5 pg/ml."patient 11" initial result was 393.8 pg/ml.The repeat result was 531.4 pg/ml.The questionable results were reported outside of the laboratory.The e601 module serial number was (b)(4).

Manufacturer Narrative

Calibration signals were slightly lower than expected for all calibrations performed between (b)(6) 2023.Qc results on (b)(6) 2023 were acceptable.The customer stated that the questionable results were generated using a reagent that had not been tested with qc.The field service engineer (fse) visited the customer site on (b)(6) 2023.The measuring cell was replaced and instrument performance testing was completed.The customer had no further issues after the service visit.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16631314
• MDR Text Key: 312953619
• Report Number: 1823260-2023-00998
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 05/09/2023

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 Expiration Date: 12/31/2023
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 66190701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/09/2023
• 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
• Patient Sex: Male