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 INNOVA PLATE STREAKER 441863 manufactured by Bd Diagnostic Systems.
[3321488]
The bd innova instrument is intended to completely automate the front-end setup of liquid microbiology samples according to user-defined procedures and protocols. During a recent visit to the customer site a bd field service engineer noticed that there was no cool time between the loop being sterilized and the sampling from the pt specimen. The sampling of the specimen with a hot loop could potentially cause a false negative culture result. Bd medical dept provided the following analysis of the situation: in the setting in which a urinary tract infection is present and a false negative result is reported to the clinician, the clinician might either discontinue antimicrobial therapy or not initiate antimicrobial therapy when it is needed. It is possible that if no therapy is given the infection could worsen and lead to sepsis which might require hospitalization. This risk would be mitigated in that the clinician is likely to repeat cultures from the urine and other sources if the pt had continued to have symptoms.
Patient Sequence No: 1, Text Type: D, B5
[10656071]
Bd informed the customer of the issue at the time it was noticed. As part of the investigation bd asked the customer to examine their positivity reports for any decreases and also to examine the quality control testing they perform on the urines for each drawer. The customer did not see any changes in positivity levels and all urine qc samples performed as expected. At this time, we do not know of any instance where a customer sample was reported as false negative. Investigation at the customer site on the instrument revealed that on (b)(4) 2012 a service engineer was on site to fix a separate issue. During this visit, the rsst value in the instrument specific csv file was set to +90 degrees but should have been set to -90 degrees. This caused the instrument to not alternate between two loops which rotate 180 degrees from each other. This cased the instrument to use only one loop which in turn did not allow cool time because the loops did not alternate usage. Bd determined that all engineers were sufficiently trained. Other instruments were examined and no other evidence was presented to indicate the csv file had been modified. At this time, it appears that this was a result of a clerical mistake by the engineer servicing the instrument on (b)(4) 2012. No other incidents of this type have been reported or discovered during this investigation which indicates this is an isolated event. A corrective action will be taken to prevent recurrence of this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2013-00003 |
| MDR Report Key | 3037125 |
| Report Source | 05 |
| Date Received | 2013-03-08 |
| Date of Report | 2013-02-08 |
| Date of Event | 2012-12-20 |
| Date Mfgr Received | 2013-02-08 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2013-05-14 |
| 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 | 7 LOVETON CIR. |
| 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 INNOVA PLATE STREAKER |
| Product Code | MKZ |
| Date Received | 2013-03-08 |
| Catalog Number | 441863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |