MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12); AB12 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	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All test results are analysed with reagent lot 32689016.The customer noticed variation/bias within ab12 reagent lot 32689016 in the low end of results in quality contol (qc) and with patient results.The reagent is not homogenous, particles/sediment can be seen in the bottom of the reagent readypack from the last two shipments.The same lot has been performing as specified earlier.The customer is calibrating ab12 assay more often and is also running qc as well.The customer received ab12 lot 33437017 for troubleshooting.The low control result on the advia centaur xpt 3 was 13.9 and the next morning the result was 20.The ranges for ab12 qc results are 11.7 to 19.5 for the low control and 45.3 to 75.5 for the high control.The reagent seemed to have also a sediment in the bottom of the reagent readypack.Siemens healthcare diagnostics is investigating the cause of the discordant ab12.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
Discordant high advia centaur xpt active-b12 (holotranscobalamin) (ab12) results were obtained on a patient sample.The customer observed the reagent is not homogenous, particles/sediment can be seen in the bottom of the reagent readypack for lot 32689016.The initial testing was on (b)(6) 2018 and the repeat testing was on (b)(6) 2018.The results were not reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the ab12 discordant results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00258 on october 16, 2018.On 11/15/2018 additional information: the oem manufacturer performed an onboard stability study with reagent lots 016 and 017 with quality control (qc) lot 313643398.Reagents were on board for 7 days starting 11/01/2018 and tested at 5 time points on 11/01, 11/02, 11/03, 11/06, and 11/07.Each reagent pack was inspected for settling on each day of testing.No settling was observed.All replicates and means were within specified control ranges for each time point.Because control values are consistently recovering on the high end of specification, further investigation is pending.The particle settling was not confirmed from this study.Siemens healthcare diagnostics continues to investigate.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00258 on october 16, 2018.Siemens filed the mdr 1219913-2018-00258 supplemental report 1 on november 29, 2018.12/20/2018 additional information: the customer started to use new ab12 reagent lot 019 on (b)(6) 2018.The reagent lot 019 is performing as specified.Siemens healthcare diagnostics continues to investigate.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00258 on october 16, 2018.Siemens filed the mdr 1219913-2018-00258 supplemental report 1 on november 29, 2018.Siemens filed the mdr 1219913-2018-00258 supplemental report 2 on january 07, 2019.On 03/28/2019 additional information: the oem manufacturer performed studies to investigate the observed high bias control recovery.Siemens complaint investigation included a multi-lot study and determined active-b12 (ab12) qc level 1 and 2 high bias to target, with intermittent level 1 failures on the advia centaur xp/xpt/cp with ab12 reagent lots 150016 and 150017.Investigation evaluated mcm performance and showed intermittent mcm level 2 and 3 failures on the advia centaur cp only.Patient performance is not impacted with reagent lots 150016 and 150017 and clinical utility of the assay remains intact.

• Brand Name: ADVIA CENTAUR XPT ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12)
• Common Device Name: AB12 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7970421
• Report Number: 1219913-2018-00258
• Device Sequence Number: 202126
• Product Code: CDD
• UDI-Device Identifier: 00630414603100
• UDI-Public: 00630414603100
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K160757
• 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,Followup
• Report Date (Section B): 04/08/2019

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: 03/13/2019
• Device Model Number: N/A
• Device Catalogue Number: 10995088
• Device Lot Number: 32689016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/15/2018; 12/20/2018; 03/28/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/29/2018; 01/07/2019; 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1