MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM SARS-COV-2 TOTAL (COV2T); SARS-COV-2 IMMUNOASSAY

Model Number N/A

Device Problems False Negative Result (1225); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

The calibration was acceptable and the quality control (qc) was within range.The customer stated that they batch their covid sample test and the atellica im is cleaned before and after the runs, per instructions for use (ifu).The customer stated that a few other covid samples were run along with this patient sample and no other patient sample results are being questioned.Siemens healthcare diagnostics is investigating.The ifu states in the limitations section: "patient specimens may be nonreactive if collected during the early (pre-seroconversion) phase of illness or due to a decline in titer over time.In addition, the immune response may be depressed in elderly, immunocompromised, or immunosuppressed patients." a false negative/non-reactive result would be correlated with clinical history and presentation and may lead to additional testing and/or continued precautions to avoid infection with negligible clinical impact.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 1219913-2020-00147 was filed for the same patient sample on a different test date.

Event Description

The customer obtained a discordant nonreactive (negative) atellica im sars-cov-2 total (cov2t) result for a patient sample on (b)(6) 2020.The sample was repeated on the atellica im sars-cov-2 total (cov2t) assay on (b)(6) 2020 and the result was again nonreactive.The patient sample was initially tested on (b)(6) 2020 using the pcr method at (b)(6) and the result was positive.The patient sample was retested at (b)(6) using the pcr method on (b)(6) 2020 and a negative result was obtained.The initial atellica im result was reported to the physician and was not questioned.There are no known reports of patient intervention or adverse health consequences due to the nonreactive cov2t results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00148 on (b)(6) 2020.(b)(6) 2020 correction: in the initial mdr report section d2, the incorrect product code was documented.The correct product code is qko.Section d2 has been updated with this information.In the initial mdr report section h4, the device manufacture date was inadvertently omitted.The device manufacture date is (b)(6) 2020.Section h4 has been updated with this information.(b)(6) 2020, additional information: siemens has investigated this incident.The patient sample is no longer available for further testing and investigation and patient symptomology is not available, therefore, siemens is unable to determine the root cause.The atellica im cov2t ifu (11206906_en rev.(b)(6) 2020) states positive agreement is 100% with a 95% confidence interval of 91.59-100.0%.Siemens is unable to rule out a sample specific issue.Based on the information provided, no product problem is identified.The instrument is performing within specifications.No further evaluation of the device is required.Section h6, the device, method, results and conclusion codes were updated to reflect the additional information.Mdr 1219913-2020-00147 supplemental report 1 was filed for the same patient sample on a different test date.

• Brand Name: ATELLICA IM SARS-COV-2 TOTAL (COV2T)
• Type of Device: SARS-COV-2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10185226
• MDR Text Key: 196650034
• Report Number: 1219913-2020-00148
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EUA201367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206711
• Device Lot Number: 001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1