MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-13 for BD VERITOR PHYSICIAN KIT - FLU A AND B 256045 manufactured by Bd Diagnostic Systems.
[5372297]
(b)(6) hosp reported that a (b)(6) -old infant was being treated for flu a based on a positive bd veritor test result processed on (b)(6) 2015. The infant was transported to (b)(6). A new sample was collected at (b)(6) and tested for flu a and the results were negative (date has not been confirmed at this time). The lab at (b)(6) reran the original specimen (collected on (b)(6) 2015) on the bd veritor and received a negative result on (b)(6) 2015. (b)(6) then sent the original specimen (collected on (b)(6) 2015) to (b)(4) for influenza a and b pcr rna test and received a negative result. The infant was removed from life support on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
[12818555]
The bd veritor system for rapid detection of flu a and b is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza a and b viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic pts. The bd veritor system for rapid detection of flu a and b (also referred to as the bd veritor system and bd veritor system flu a and b) is a differentiated test, such that influenza a viral antigens can be distinguished from influenza b viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza a and b viral infections. Results from the bd veritor system for rapid detection of flu a and b test should be correlated with the clinical history, epidemiological data and other data available to the clinician evaluating the pt. Bd has requested additional info from the (b)(6) hosp and (b)(6) hosp regarding the incident. Bd has also requested the return of the bd veritor kit and reader for investigation. Bd will file a supplemental report when additional info is provided and investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2015-00001 |
| MDR Report Key | 4422662 |
| Report Source | 06 |
| Date Received | 2015-01-13 |
| Date of Report | 2015-01-09 |
| Date of Event | 2015-01-08 |
| Date Mfgr Received | 2015-01-09 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2015-01-15 |
| 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 | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BD RAPID DIAGNOSTICS CO LTD |
| Manufacturer Street | 9 RUI PU RD |
| Manufacturer City | SUZHOU JIANGSU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VERITOR PHYSICIAN KIT - FLU A AND B |
| Product Code | GNX |
| Date Received | 2015-01-13 |
| Catalog Number | 256045 |
| Lot Number | 4259123 |
| Device Expiration Date | 2017-02-10 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-01-13 |