MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-06-27 for APPLIED BIIOSYSTEMS 7500 FAST DX REAL-TIME PCR 4407205 manufactured by Life Technologies Holdings Pte Ltd.
[4823344]
A customer reported poor data obtained from a run using the applied biosystems 7500 fast dx real-time pcr instrument (catalog no. 4407205 serial no. (b)(4)). Data was wavy and had large gaps in amplification plot. No pt involvement was reported. The company event tracking no: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11939105]
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. Device intended use: the applied biosystems 7500 fast dx real-time pcr instrument with the sds software version 1. 4 is a real-time nucleic acid amplification and detection system that measures nucleic acid signals from reverse transcribed rna and converts them to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. The 7500 fast dx real-time pcr instrument is to be used only by technologists trained in laboratory techniques, procedures and on use of the analyzer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003673482-2014-00017 |
| MDR Report Key | 3978867 |
| Report Source | 04,07 |
| Date Received | 2014-06-27 |
| Date of Report | 2013-04-19 |
| Date of Event | 2013-04-19 |
| Date Mfgr Received | 2013-04-19 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-08-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KELLI TANZELLA |
| Manufacturer Street | 3175 STALEY RD |
| 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 | APPLIED BIIOSYSTEMS 7500 FAST DX REAL-TIME PCR |
| Generic Name | INSTRUMENTATION FOR CLINICAL MULTIP |
| Product Code | NSU |
| Date Received | 2014-06-27 |
| Catalog Number | 4407205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |