MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-12 for ABBOTT REALTIME CT/NG ASSAY LIST NO. 8L07-90 & 8L07-91 manufactured by Abbott Molecular, Inc..
[16535760]
Description of deficiency: complaint investigation (b)(4) was initiated to investigate complaint (b)(4) following fill issues that were found by internal abbott molecular personnel during investigational use. Complaint investigation confirmed fill issues for several enzyme parts and lots. Under filled and over filled vials may result in obtaining less than the total number of tests per kit as described in the package insert. The abbott realtime ct/ng assay was affected along with the abbott realtime hiv-1 assay and abbott realtime hbv assay. With the exception of ct/ng the tests done on this system are not used for acute disease management and a delay of 3 days would not impact patient management, as the clinically relevant time to result required for patient management is greater than 3 days. A delay of 3 days for ct/ng results could potentially impact management. A delay in results for the realtime ct/ng and realtime ct assays has the potential to impact patient management. The results are used by clinicians to aid in the diagnosis of acute urethral and cervical infections. If there is a delay in diagnosis, there is the potential that initiation of appropriate treatment will be delayed. Complications of chlamydial and gonococcal infections can result. In addition, delay in diagnosis can potentially lead to unknowing spread of the contagious illness. Device intended use: abbott realtime ct/ng assay: list number 8l07-90 - the abbott realtime ct/ng assay is an vitro polymerase chain reaction (pcr) assay for the direct, qualitative detection of the plasmid dna of chlamydia trachomatis and the genomic dna of neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine. List number 8l07-91 - the abbott realtime ct/ng assay is an in vitro polymerase chain reaction (pcr) assay for the direct, qualitative detection of the plasmid dna of chlamydia trachomatis and the genomic dna of neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals; female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.
Patient Sequence No: 1, Text Type: D, B5
[16626636]
Abbott molecular to distribute field advisory notice and customer reply form via (b)(4) to united states customers based on customer receipt of realtime hiv-1, realtime hbv and realtime ct/ng amplification reagent kit (as assay cannot be run without amplification reagent, eg, calibrator or controls only), list numbers 6l18-90, 8l07-90, 8l07-91 and 2n40-90. Technical bulletin will be made available to provide technical services background of issue and instructions for call registration. There are two applicable 510 (k): k080739 and k092704. Interim action was implemented within (b)(4), sam filling procedure, to convert from a visual check of 125 vials into a weight check of 125 vials, thereby providing a new mode of control to detect lots with vials outside of specification. Note, the sampling of 125 vials via weight method will allow 95% confidence that the defect rate per lot is 0. 29% or lower at an aql% of 0. 40. Document changes were processed to clarify and standardize verbiage in the filling operation procedures ((b)(4), set-up and operation of the calibrator/control filling machine, (b)(4), internal control filling machine, and/or (b)(4), sam filling procedure) for handling and filling products for the semi-automated (sam) fillers. Intent of the document clarifications was to minimize errors that potentially can be introduced by equipment or human errors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2010-00009 |
| MDR Report Key | 2796713 |
| Report Source | 07 |
| Date Received | 2011-01-12 |
| Date of Report | 2010-12-06 |
| Date of Event | 2010-11-06 |
| Date Mfgr Received | 2010-11-06 |
| Date Added to Maude | 2012-10-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAMELA SWATKOWSKI |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617013 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT REALTIME CT/NG ASSAY |
| Product Code | MKZ |
| Date Received | 2011-01-12 |
| Catalog Number | LIST NO. 8L07-90 & 8L07-91 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-12 |