MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2014-06-27 for QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT 4470660 manufactured by Life Technologies Holdings Pte., Ltd..
[4631474]
A customer reported a lamp error and instrument failed self test that would cause a run to not start or not generate results after assay completion. The medical device involved was quanstudio dx real-time pcr instrument (cat # 4470660, serial# (b)(4)). No pt involvement reported. The company event tracking number is: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12217001]
Device is an instrument and is not implanted / explanted. The instrument was investigated on site and was repaired by replacing the lamp and motor controller board. After replacement, functional tests were performed to verify the instrument functionality. Device intended use: the quantstudio dx real-time pcr instrument with quantstudio dx software is intended to perform fluorescence-based pcr to provide detection fo fda cleared and approved nucleic acid sequences in human-derived specimens. The quantstudio dx real-time pcr instrument with quantstudio dx software is intended for in vitro diagnostic use by trained lab technologists in combination with neucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003673482-2014-00012 |
| MDR Report Key | 3978988 |
| Report Source | 01,04,07 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-03-31 |
| Date of Event | 2014-03-31 |
| Date Mfgr Received | 2014-03-31 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-08-13 |
| 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 |
| 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 | 7167437743 |
| Manufacturer G1 | LIFE TECHNOLOGIES PTE, LTD. |
| Manufacturer Country | SN |
| 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 | 2014-06-27 |
| Catalog Number | 4470660 |
| 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 | SINGAPORE SN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-27 |