HYBRID CAPTURE 2 RAPID CAPTURE SYSTEM 9000192 6000-3101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-09-13 for HYBRID CAPTURE 2 RAPID CAPTURE SYSTEM 9000192 6000-3101 manufactured by Digene Corp..

Event Text Entries

[259255] The hybrid capture 2 (hc2) rapid capture system (rcs) is a semi-automated instrument application of the hc2 ct/gc, ct-id and gc-id dna tests. The application uses a robotic microplate processor that automates the pipetting and microplate handling steps of the hc2 tests. Complaint reported that 3 specimens of 40 were not transferred in training conducted at a new customer site. Two missed specimens were training panel simulated specimens. One was a digene cervical sampler without patient specimen. The report indicated that the rcs functioned as expected. The missed transfers were identified prior to processing in the routine transfer verification step, as described in the application manual instruction, and were corrected by manual pipetting before processing. The report noted air pockets, also referred to as 'air bubbles", in the specimens after vortexing. Initial review concluded that the report did not pertain to or have the potential to cause injury. No patient specimens were involved. Simulated specimens were in use for training purposes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1122376-2002-00001
MDR Report Key417453
Report Source07
Date Received2002-09-13
Date of Report2002-05-30
Date of Event2002-05-29
Date Mfgr Received2002-05-29
Device Manufacturer Date2001-09-01
Date Added to Maude2002-09-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSARA SCHROEDER, QSRC DIRECTOR
Manufacturer Street1201 CLOPPER ROAD
Manufacturer CityGAITHERSBURG MD 20878
Manufacturer CountryUS
Manufacturer Postal20878
Manufacturer Phone3019447274
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionMA
Previous Use Code3
Removal Correction NumberPPI07/02A
Event Type3
Type of Report3

Device Details

Brand NameHYBRID CAPTURE 2 RAPID CAPTURE SYSTEM
Generic NameROBOTIC PLATE PROCESSOR FOR HC2 CT/GC DNA TEST
Product CodeLSK
Date Received2002-09-13
Model Number9000192
Catalog Number6000-3101
Lot NumberNA
ID NumberNA
OperatorOTHER
Device AvailabilityY
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key406484
ManufacturerDIGENE CORP.
Manufacturer Address1201 CLOPPER RD GAITHERSBURG MD 20878 US
Baseline Brand NameHYBRID CAPTURE 2 RAPID CAPTURE SYSTEM
Baseline Generic NameROBOTIC PLATE PROCESSOR FOR HC2 CT/GC DNA TEST
Baseline Model No9000192
Baseline Catalog No6000-3101
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-09-13

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