MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for BD VIPER? LT SYSTEM 442839 manufactured by Becton, Dickinson & Co..
[35411505]
The bd viper lt system is intended for in vitro diagnostic (ivd) use in clinical laboratories to perform automated extraction of nucleic acids from multiple specimen types, amplification of target nucleic acid sequences by strand displacement amplification (sda) and detection of amplified nucleic acid using a two color fluorescence detection system. The bd viper lt is for use only with in vitro diagnostic tests labeled for use on the system. Bd quality has confirmed the complaint of lower than expected rfu values generated on the viper? Lt system after the installation of software v3. 00h. Only two customers were upgraded to this software version which caused positive control failures and lower rfu signal for ct/gc controls at both sites. As rfu values decrease, results approach the assay cutoff threshold which has the potential to impact test results. Both customer instruments were reverted to the previous software version, 2. 93b, on (b)(6) 2015 and both have resumed clinical specimen testing. Bd quality will continue to monitor for trends. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[35411506]
After upgrade of viper lt v3. 00h at customer site, positive control failures were observed. Positive control results exhibited low rfu values that were below expected results. As rfu values decrease, results approach the assay cutoff threshold which has the potential to impact test results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001119779-2016-00001 |
| MDR Report Key | 5343747 |
| Date Received | 2016-01-05 |
| Date of Report | 2016-01-04 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2015-12-09 |
| Device Manufacturer Date | 2014-12-18 |
| Date Added to Maude | 2016-01-05 |
| 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 CAROL NIETO |
| 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 |
| Removal Correction Number | 1119779-12/14/2015-C-12 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VIPER? LT SYSTEM |
| Generic Name | REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM |
| Product Code | OOI |
| Date Received | 2016-01-05 |
| Catalog Number | 442839 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2016-01-05 |