ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX 102860

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-14 for ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX 102860 manufactured by Hologic, Inc..

Event Text Entries

[86257887] The customer, (b)(6) at (b)(6), obtained a patient isolate at the end of (b)(6). The patient sample was grown on a mycobacteria growth indicator tube (mgit) and the smear was acid-fast bacilli (afb) positive and exhibited "dragon" cording, consistent with mycobacterium tuberculosis complex (mtbc) morphology. The customer tested the patient sample using hologic's accuprobe mycobacterium tuberculosis complex culture identification test and twice obtained a negative result. Customer stated they are confident this patient has tuberculosis. The run results were reviewed by hologic, which demonstrated that the control values were strong and that there were other positive samples in the run obtained by the customer. The customer retested the original specimen using the cepheid genexpert mtb/rif assay and found the specimen to be mtbc-positive. The genexpert mtb/rif assay is a newer generation system that uses real-time polymerase chain reaction (pcr) to amplify the target dna strands for detection, while the accuprobe system is a non-amplified detection system. Combined, these data suggests that the accuprobe mtbc test potentially gave a false negative result. Additional samples taken from the same patient resulted in positive results using the accuprobe mtbc kit. Per preliminary risk assessment, several factors that may contribute to obtaining a false negative result using the accuprobe mtbc assay. These include: a manufacturing defect, a compromised kit due to storage at the customer site, or samples that have been improperly prepared. There have been no other similar complaints for the same lot in the last 12 months. The original sample was returned to hologic and will be investigated under (b)(4). A final risk assessment will be performed following the investigation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024800-2017-00024
MDR Report Key6867429
Date Received2017-09-14
Date of Report2017-11-28
Date of Event2017-08-18
Date Mfgr Received2017-08-18
Date Added to Maude2017-09-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JULIETTE BUSSE
Manufacturer Street10210 GENETIC CENTRE DR.
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8584108799
Manufacturer G1HOLOGIC, INC.
Manufacturer Street10210 GENETIC CENTER DR.
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal Code92121
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX
Generic NameIN-VITRO DIAGNOSTICS
Product CodeLQF
Date Received2017-09-14
Returned To Mfg2017-09-07
Catalog Number102860
Lot Number216323H
Device AvailabilityR
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC.
Manufacturer Address10210 GENETIC CENTER DR. SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-09-14

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