MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. VERSANT KPCR MOLECULAR SYSTEM SP; CLINICAL SAMPLE CONCENTRATOR

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer noticed an increase in the incidence of low-positive determinations for the ftd sars-cov-2 assay.[fast track diagnostics (ftd) is a siemens healthineers company.] samples which had produced low-positive results in this assay over a three-day period ((b)(6) 2021) were re-tested using an alternate instrument system.7 of the samples which had previously tested positive during this period were found to be negative upon re-test.Specific patient data were not provided.Following these observations of discordant positive results, the versant kpcr molecular system sp (sample preparation instrument) was subjected to a cleaning/decontamination procedure, and improvement was observed in blank-sample testing.It is concluded that a likely nucleic-acid contamination occurred within the versant kpcr molecular system sp instrument during operator/assay interactions, leading to the observed elevation of results.No product malfunction was identified.No further evaluation of the product is required.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).Mdr 1219913-2021-000146 was filed for results generated on (b)(6) 2021; mdr 1219913-2021-00147 was filed for results generated on (b)(6) 2021 and mdr was filed for results generated on (b)(6) 2021.
Event or Problem Description
The customer observed falsely-elevated results for the ftd sars-cov-2 assay as a result of contamination of the versant kpcr molecular system sp.[fast track diagnostics (ftd) is a siemens healthineers company.] the samples in question were re-tested using an alternate system, and produced negative results, which were reported as correct.There are no known reports of patient intervention or adverse health consequences due to the discordant sars-cov-2 results.

• Brand Name: VERSANT KPCR MOLECULAR SYSTEM SP
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11351252
• Report Number: 1219913-2021-00148
• Device Sequence Number: 14470520
• Product Code: JJH
• UDI-Device Identifier: 00630414541457
• UDI-Public: 00630414541457
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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 Model Number: N/A
• Device Catalogue Number: 10282928
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1