MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION®; DIMENSION® CV2T SARS-COV-2 TOTAL ANTIBODY ASSAY

Model Number	11417412
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens customer care center to report a discordant negative dimension sars-cov-2 total antibody (cv2t) patient sample result obtained on a dimension exl 200.Although there is no potential for serious injury in this case, an mdr will be reported to the fda as a requirement of the emergency use authorization (eua).Siemens is investigating the event.
Event or Problem Description
A discordant negative dimension sars-cov-2 total antibody (cv2t) patient sample result was obtained on a dimension exl 200 system.The result was not reported to the physician(s).The same patient sample was reprocessed on the same system the next day and a positive result, considered correct, was obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant dimension cv2t patient sample result that was not reported to the physician(s).
Additional Manufacturer Narrative
Additional information (09-nov-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the discordant false negative dimension sars-cov-2 total antibody (cv2t) patient sample result.Hsc reviewed the instrument data logs and the information provided by the customer.Quality control processed prior to the sample testing was within laboratory acceptance range.There were no reports of any other discordant patient sample results.This was an isolated event.A potential product issue has not been identified.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2021-00294 was filed 25-oct-2021.Although there is no potential for serious injury in this case, an mdr was reported to the fda as a requirement of the emergency use authorization (eua).

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® CV2T SARS-COV-2 TOTAL ANTIBODY ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 12688522
• Report Number: 2517506-2021-00294
• Device Sequence Number: 17168686
• Product Code: QKO
• UDI-Device Identifier: 00630414605418
• UDI-Public: 00630414605418
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EUA201460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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: 01/21/2022
• Device Model Number: 11417412
• Device Catalogue Number: RF812 SMN 11417412
• Device Lot Number: EB2021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown