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

Catalog Number	07028121190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer's level 2 of quality control was not acceptable on the day of the event.The customer was not performing analyzer maintenance (liquid flow cleaning) as required.Per product labeling for the assay: for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.The recommended 1:2 dilution was not performed as the customer's internal protocol is to not dilute vitamin b12 samples as they do not consider it clinically relevant.The analyzer alarm trace showed that foam was detected on a sample on the date of the event.Therefore sample quality issues may be present at the customer site.The investigation is ongoing.
Event or Problem Description
There was an allegation of high vitamin b12 g2 elecsys results from the cobas pure e 402 analytical unit serial number (b)(4) for 1 patient which reportedly led to a bone marrow aspiration.The initial result was reportedly 1476 pmol/l with a data flag and was reported outside of the laboratory.A new sample was drawn and the result was reportedly 1476 pmol/l with a data flag.After the first results, a bone marrow aspiration was reportedly performed to try to understand the pathology.The aspiration allegedly "went well and the result was ok".On (b)(6) 2023, one of the samples was retested at an external laboratory on a cobas e801 analyzer and the result was <111 pmol/l.On (b)(6) 2023, the other sample was retested on a cobas e801 analyzer at the external laboratory and the result was <111 pmol/l.Allegedly, the patient would have been treated with b12 supplementation instead of undergoing a bone marrow aspiration.
Additional Manufacturer Narrative
The investigation did not identify a product problem with the instrument or reagent.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN B12 II
• Common Device Name: 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: 16645606
• Report Number: 1823260-2023-01010
• Device Sequence Number: 6203866
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K060755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 07028121190
• Device Lot Number: 63305201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Unknown