MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM VITAMIN B12; VITAMIN B12 IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer communicated that they suspect the atellica im vb12 the dtt/releasing agent was not prepared according to instructions in the instructions for use (ifu).Siemens is investigating.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
A falsely elevated result was obtained using the atellica im vitamin b12 (vb12) assay and was reported to the physician.It is unknown if the physician questioned the result.The sample was retested in triplicate using 2 different atellica im instruments.The customer issued a corrected report to physician, averaging the three repeat replicates.There is no report that treatment was altered or prescribed and no report of adverse health consequences due to the falsely elevated atellica im vb12 result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2019-00119 on june 28, 2019.On 08/08/2019: additional information: atellica im vb12 dtt/rel kit, material no.: 10995718, gtin (b)(4), lot no.01370010a, exp.Date 2020/01/01 was used when the elevated result was obtained.The following information was obtained during the investigation: controls recover lower (it is unknown if controls were with in acceptable ranges).Initial and repeat results for the sample in question ((b)(6)) used the same calibration.Sample was under refrigeration until repeat testing was performed.Initial and repeat results for the sample in question ((b)(6)) were tested approximately 1-2 hrs apart.Physician did not question the initial result; the discordant result was noticed internally by laboratory staff and corrected reports were issued the following morning.Siemens continues to investigate this event.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2019-00119 on june 28, 2019.Siemens filed mdr 1219913-2019-00119 supplemental report 1 on august 29, 2019.Additional information from 09/04/2019: siemens' investigation is complete.The initial issue was reported as a high vb12 result of 755 pmol/l on one atellica im 1600 and a repeated result of 97 pmol/l (mean of 3 replicates in pmol/l: 96,94,101) on a different atellica im 1600 instrument.This was the only result that was initially high and repeated low; other patients had decreased results and repeated in the normal range.The issue was identified by the laboratory and physician was not involved before the corrected result was issued.Based on the information available, there is evidence that an incorrect amount of dtt was added, or omitted altogether, in preparing the dtt/releasing agent for the original patient sample.There is no report that treatment was altered or prescribed and no report of adverse health consequences as a result of this event.No other issues have been reported by the customer since the event.No systemic product non-conformance was recognized.The incident appears to be singular in nature.The instructions for use states the following in the preparing the reagents section: "use this procedure to prepare the dtt/releasing agent.Note: careful preparation of dtt/releasing agent is required to obtain accurate and consistent results since the absolute amount of dtt delivered for each test can affect results.Prepare the dtt/releasing agent immediately before using.Use the prepared dtt/releasing agent within 108 hours.1.Add 300 ul dtt to 12.0 ml releasing agent in a test tube using a volumetric pipet.2.Mix the dtt and releasing agent in the test tube.Cover the test tube with self-sealing laboratory film and invert the test tube several times to mix.3.Remove the self-sealing laboratory film and pour the entire contents into the disposable readypack ancillary reagent pack provided.4.Place a pack seal on the disposable ancillary reagent pack.Ensure that the seal is centered over the opening of the pack, and press firmly on the adhesive portion of the seal.Note: dtt/releasing agent readypack ancillary reagent packs are lot-number-specific.Do not use packs from one lot of dtt/releasing agent with any other lot of dtt/releasing agent." based on the investigation, no product problem was identified.No further evaluation of the device is required.

• Brand Name: ATELLICA IM VITAMIN B12
• Common Device Name: VITAMIN B12 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8746334
• Report Number: 1219913-2019-00119
• Device Sequence Number: 13788591
• Product Code: CDD
• UDI-Device Identifier: 00630414600284
• UDI-Public: 00630414600284
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K993571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2019
• Device Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 28162253
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 09/04/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/29/2019; 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1