MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM HEPATITIS C (AHCV); HEPATITIS C VIRUS IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of reproducible nonreactive (negative) atellica im hepatitis c (ahcv) results for one patient which were discordant relative to patient history and alternate-method testing.The patient in question produced a series of three nonreactive ahcv results in repeat testing.The patient had a history of positive hcv results by an alternate testing method (going back to 2016); the negative ahcv results were considered incorrect and not reported.The sample was also tested following treatment with inhibitors of heterophilic antibodies (heterophilic blocking tube, hbt) for investigation/troubleshooting, and produced a negative result.Using heterophilic-blocking tube).There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of reproducible nonreactive (negative) atellica im hepatitis c (ahcv) results for one patient which were discordant relative to patient history and alternate-method testing.No issues were observed with any other patient samples, and quality control (qc) results were within expected ranges.The ahcv instructions for use (ifu) states the following, under interpretation of results: ¿results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.¿ the following is stated under limitations: ¿patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis.¿ siemens is investigating.
Additional Manufacturer Narrative
Mdr 1219913-2023-00159 was initially submitted on 2023-08-10.A customer from outside the united states observation of reproducible nonreactive (negative) atellica im hepatitis c (ahcv) results for one patient which were discordant relative to patient history and alternate-method testing.There were no apparent problem indications at the time of the discordant observations.The issue appears isolated to a particular patient/sample.The customer returned an earlier sample (taken three years earlier) from the same patient for additional testing; the sample which generated the discordant nonreactive result was not returned.The earlier sample had produced reactive results at the time of initial testing.Siemens tested this sample using three lots of ahcv reagent: lots 448 (indicated in complaint), 457, and 463.All three reagent lots produced similar reactive results, reproducing the customer¿s result of three years prior.This indicates no apparent lot-to-lot differences with respect to measurement.The later nonreactive results observed for this patient are consistent with a drop in hcv titer associated with an older infection.As the initial positive result for the earlier sample was not strongly reactive, the nonreactive results obtained are not inconsistent with expected assay behavior.No product problem was identified.The customer is operational, and no further action is required.Notes: 1) in section b6, data from testing of earlier patient sample are included.2) in section h6, the codes for type of investigation, investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM HEPATITIS C (AHCV)
• Common Device Name: HEPATITIS C VIRUS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; tarrytown 10591 ; 5082985306
• MDR Report Key: 17503030
• Report Number: 1219913-2023-00159
• Device Sequence Number: 6353827
• Product Code: MZO
• UDI-Device Identifier: 00630414597867
• UDI-Public: 00630414597867
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030056
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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: 03/06/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995456
• Device Lot Number: 448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown