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 Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

The customer found a brown microbead ring on one of the affected reagent packs.Based on the provided qc data, a general reagent issue could most likely be excluded.The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable vitamin b12 g2 elecsys results for qc material and three patient samples from cobas e411 rack analyzer serial number (b)(4).The customer replaced the reagent, recalibrated the assay and repeated the samples.Sample 1 initial result was 135.9 pg/ml and the repeat result was 348.2 pg/ml.Sample 2 initial result was 118.4 pg/ml and the repeat result was 227.7 pg/ml.Sample 3 initial result was 195.6 pg/ml and the repeat result was 301.7 pg/ml.It was unknown if the questionable results were reported outside of the laboratory.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.A handling issue at the customer site could not be excluded as the customer uses the reagent kits longer than the specified stability as per product labeling.Inappropriate storage/transportation conditions at the customer site could not be excluded based on the brown microbead ring visible on one of the affected kits.A general reagent issue can most likely be excluded as the customer qc data was within the specified ranges.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10352271
• MDR Text Key: 202057841
• Report Number: 1823260-2020-01850
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

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: 10/31/2020
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 44583501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1