MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-05-02 for QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT 4484383 manufactured by Life Technologies Holdings Pte. Ltd..
[4642919]
A customer reported a software bug which resulted in incorrect sample identification. When one sample on a plate was assigned a new identifier, the rest of the samples on the plate were automatically renamed. Additionally, a pop-up error message appeared on the screen. The medical device involved was quantstudio dx real-time pcr instrument (catalog no. 4484383, serial no. (b)(4)). No patient involvement reported. The company event tracking no. Is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11982134]
Implant and explant dates: device is an instrument and is not implanted/explanted. The instrument was investigated on site. The root cause was determined to be a software design issue which prevented the customer from obtaining results after a run. To by-pass the software issue, the field application specialist instructed the customer on how to use the "import from file" function in the software. This allowed the customer to obtain results after the run. The software issue has been addressed and a new version of the software is scheduled for release.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003673482-2014-00009 |
| MDR Report Key | 3949740 |
| Report Source | 04,07 |
| Date Received | 2014-05-02 |
| Date of Report | 2013-10-24 |
| Date of Event | 2013-10-24 |
| Date Mfgr Received | 2013-10-24 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-07-31 |
| 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 | KELLI TANZELLA |
| Manufacturer Street | 3175 STALEY ROAD |
| Manufacturer City | GRAND ISLAND NY 14072 |
| Manufacturer Country | US |
| Manufacturer Postal | 14072 |
| Manufacturer Phone | 7167743122 |
| Manufacturer G1 | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT |
| Generic Name | REAL TIME NUCLEIC ACID AMPLIFICATION |
| Product Code | OOI |
| Date Received | 2014-05-02 |
| Catalog Number | 4484383 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. |
| Manufacturer Address | SN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-02 |