ROCHE MOLECULAR SYSTEMS, INC. COBAS MPX TEST, CE-IVD; ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA
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Catalog Number 06997716190 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation of this issue is on-going and final conclusions will be shared in a follow-up report.The material number for the cobas mpx test, 480t, (b)(4).The udi for the cobas mpx test, 480t, us-ivd is (b)(4).------ (b)(4).
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Event Description
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A customer from (b)(6) alleged discrepant results between serology and cobas mpx testing for a donor, with the cobas mpx test consistently generating non-reactive results.Depending on the serology test used, a mixture of positive and negative serology results were generated.The donor was diagnosed with lymphadenopathy, and it was indicated that he is a new donor.The blood donation was discarded.
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Manufacturer Narrative
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The donor sample from (b)(6) 2019 collection was sent to a reference lab for testing with the abbott real-time hiv-1 viral load assay.The result was target not detected, which confirms (b)(6) was not present and additional testing, including sequence analysis, would not be possible.No information was provided on any additional follow up blood draws or testing for the donor.Roche medical and scientific affairs was consulted with details of the case provided.They explained that a (b)(6) antigen test ten days following the first reaction, with no serology reactivity is unlikely for a true (b)(6) patient.With the totality of the data considered, as well as the investigation (review of qc kit release, non-conformance, etc) the cobas mpx assay has been determined to be functioning as intended.A (b)(6) result with the p24 and serology test assay is suspected.------ (b)(4).
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