MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2015-10-21 for BD PROBETEC? NEISSERIA GONORRHOEAE (GC) QX 441124 manufactured by Becton, Dickinson & Co..
[28834485]
The bd probetec? Gc qx amplified dna assay, when tested with the bd viper? System in extracted mode, uses strand displacement amplification technology for the direct, qualitative detection of neisseria gonorrhoeae dna in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay is also intended for use with gynecological specimens collected in bd surepath? Preservative fluid or preservcyt? Solution using an aliquot that is removed prior to processing for either the bd surepath or thinprep? Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease. Bd molecular quality initiated an investigation on the customer complaint regarding gc reproducibility. Quality investigation required review of the batch history record as well as functional analysis of the gc microwells from the customer reported reagent batch. The batch history records were reviewed and no discrepancies were noted. Functional analysis of the customers reported reagent batch passed with 100% gc positivity and negativity respectively. Quality was unable to produce false results within a clean system. The most likely root cause for this issue is customer error during population of the microwells during plate setup. The bd viper system contains various control mechanisms to help prevent customers from setting up the microwells in an incorrect layout. The customer receives training prior to use which includes how to populate the wells in the tray. Documentation is present in multiple resources that the customer has at their testing site including: bd viper training manual, bd viper instrument user's manual, bd viper quick reference guide. The microwells are color coded, ct qx is green/ purple and gc qx is yellow/purple. The color coding also visibly displayed in the proper order on the monitor when the user is setting up the run. Bd molecular quality will continue to closely monitor for trends associated with reproducibility. There was no corrective action taken at this time. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[28834486]
The customer reported that a total of 4 samples from a bd probetec? Chlamydia trachomatis (ct) qx amplified dna assay and bd probetec? Neisseria gonorrhoeae (gc) qx amplified dna assay on (b)(6) 2015 were reported as positive for the incorrect pathogen when these same samples were repeated between (b)(6) 2015. Three (3) samples were erroneously reported as (b)(6) and one (1) sample was erroneously reported as (b)(6). Upon retesting, the results of these 4 patients switched and all (b)(6) results were actually (b)(6) and vice versa. According to the customer, all 4 patients were treated for both (b)(6) at the time of the original report on (b)(6) 2015. The customer states that the techs most likely incorrectly placed the (b)(6) well strips in reverse order on the (b)(6) 2015 run. No adverse consequences from treatments have been reported at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2015-00004 |
| MDR Report Key | 5163731 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2015-10-21 |
| Date of Report | 2015-10-19 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2015-09-30 |
| Device Manufacturer Date | 2015-03-04 |
| Date Added to Maude | 2015-10-21 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164000 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD PROBETEC? NEISSERIA GONORRHOEAE (GC) QX |
| Generic Name | DNA-REAGENTS, NEISSERIA |
| Product Code | LSL |
| Date Received | 2015-10-21 |
| Catalog Number | 441124 |
| Lot Number | 5063781 |
| Device Expiration Date | 2016-04-30 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-21 |