MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, V2.0; HEPATITIS VIRAL B DNA DETECTION

Catalog Number	04894570190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No systemic reagent issue identified.It is possible there is a potential mutation affecting target detection.This is the most likely root cause based on the information provided including clinical picture information, pcr results, serology etc.In order to confirm, the sample was requested for sequencing, however, the customer no longer has an available sample and therefore no further confirmation can be provided.Per the method sheet, though rare, mutations within the highly conserved region of the viral genome covered by the cobas® ampliprep/cobas ® taqman® hbv test, v2.0 primers and/or probe may result in the under-quantitation of or failure to detect the virus.Detection of hbv dna is dependent on the number of virus particles present in the specimen and may be affected by specimen collection methods and patient factors, (i.E., age, presence of symptoms, and/or stage of the infection).No remaining serum for either of these samples is available.The customer issue has been alleged on the kit cap-g/ctm hbv v2.0 72tests ce-ivd (catalog no: 04894570190; udi: (b)(4) which is equivalent to the us kit; kit cap-g/ctm hbv v2.0 72tests us-ivd (catalog no: 05027012190; udi: (b)(4).Initial reporter facility name truncated due to character limit: (b)(6).
Event or Problem Description
A customer in china alleged discrepant results for one patient while using the cobas® ampliprep and cobas® taqman® hbv test, v2 (cap/ctm hbv v2).The alleged sample initially a generated positive result with a titer of 15,800 iu/ml with a competitor platform.A repeat of the sample on that system gave consistent results.A new blood draw was taken and tested on the cap/ctm hbv v2 assay and gave a result of target not detected (tnd).Then, the original and the new collected samples were retested on cap/ctm hbv v2 assay and both gave results of tnd.The new collected sample was also retested on the competitor platform and produced a positive result of 2,230 iu/ml.The positive and negative results were released.No harm is alleged.

• Brand Name: COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, V2.0
• Common Device Name: HEPATITIS VIRAL B DNA DETECTION
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 15321268
• Report Number: 2243471-2022-00744
• Device Sequence Number: 14832355
• Product Code: MKT
• UDI-Device Identifier: 00875197002706
• UDI-Public: 00875197002706
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P050028
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: 05/31/2023
• Device Catalogue Number: 04894570190
• Device Lot Number: H28797
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male