MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-08 for BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMP 441126 manufactured by Bd Diagnostic Systems.
[17563003]
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 positive ct result was actually a (b)(6) result and vice versa. This occurred over 3 runs by the same end user. All patients had to be re-called and informed that they had been misdiagnosed. (b)(6). Patient outcome: (b)(4) patients with no infection, treated unnecessarily for (b)(6). Six patients treated appropriately for (b)(6) because of (b)(6) results but in addition were potentially treated unnecessarily for (b)(6) dependant on clinic protocols. (b)(4) patients not treated appropriately for (b)(6) (but treated for (b)(6)) dependant on clinic protocols. (b)(4) patients not treated appropriately for (b)(6) (but treated for (b)(6)) dependant on clinic protocols.
Patient Sequence No: 1, Text Type: D, B5
[17646980]
The customer is a long time user of the system. The facility has received training prior to using the system. This issue appears to be isolated to a new tech in the laboratory. The system contains various warnings to help prevent customers from setting the test up in an incorrect layout. The customer receives training prior to use which includes how to populate the wells. Documentation is present in multiple resources that the customer has at their testing site including: viper training manual, viper instrument user's manual, viper quick reference guide. The microwells are color coded, (b)(6) is green/purple and (b)(6) is yellow/purple. The color coding also visibly displayed in the proper order on the monitor when the user is setting up the run. Complaint history was evaluated and this is an isolated incident. There is no trend and no other complaints of this nature. The end user at the site will be retrained. Quality will continue to monitor for this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2013-00002 |
| MDR Report Key | 2999459 |
| Report Source | 05 |
| Date Received | 2013-03-08 |
| Date of Report | 2013-01-22 |
| Date of Event | 2012-12-22 |
| Date Mfgr Received | 2013-02-07 |
| Date Added to Maude | 2013-03-13 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMP |
| Product Code | MKZ |
| Date Received | 2013-03-08 |
| Catalog Number | 441126 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2013-03-08 |