MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-13 for BD PROBETEC CHLAMYDIA TRACHOMATIC (CT) QX 441126 manufactured by Bd Diagnostic Systems.
[4166790]
The probetec qx system is used to test patient samples for the presence of (b)(6). During the set-up of the micro-wells for a (b)(6) run, the end-user incorrectly placed the (b)(6) well strips in reverse order, thereby a (b)(6) result was actually a (b)(6) result and vice versa. During the period of (b)(6) 2013, the above mentioned handling errors were made which led to eleven sample results that were incorrectly reported out. Ten patients were incorrectly given (b)(6) results and one patient was incorrectly given a (b)(6) result.
Patient Sequence No: 1, Text Type: D, B5
[11425923]
Bd molecular quality initiated an investigation on the customer complaint regarding misplacement of (b)(6) microwells that occurred during a one week timespan that resulted in the report of several incorrect results. Quality investigation required review of the viper instrument user's manual, the viper quick ref guide, and complaint history for similar occurrences. 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, (b)(4) is green/purple and (b)(4) is yellow/purple. The color coding also visibly displayed in the proper order on the monitor when the user is setting up the run. Review of bd viper complaints since launch of the system reveals that this is the second incidence of a complaint of this type and this does not constitute a trend. Quality will continue to monitor for this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2014-00004 |
| MDR Report Key | 3587602 |
| Report Source | 05 |
| Date Received | 2014-01-13 |
| Date of Report | 2013-03-06 |
| Date of Event | 2013-01-23 |
| Date Mfgr Received | 2013-03-06 |
| Date Added to Maude | 2014-01-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Street | 52 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 CHLAMYDIA TRACHOMATIC (CT) QX |
| Product Code | MKZ |
| Date Received | 2014-01-13 |
| Catalog Number | 441126 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Address | SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-13 |