MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-06-11 for 7500 FAST DX REAL-TIME PCR INSTRUMENT 4406985 manufactured by Life Technologies Holdings Pte Ltd.
[4588691]
During the operational qualification of the 7500 fast dx real-time pcr instrument (catalog no. 4406985, serial no. (b)(4)), the customer and field service engineer observed popping sounds and a burning smell. No pt involvement reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12122389]
Implant and explant dates: device is an instrument and is not implanted/explanted. The instrument was repaired by replacing the main controller board. After repair the unit was tested and passed performance specifications. Device intended use: the applied biosystems 7500 fast x 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 | 3003673482-2014-00016 |
| MDR Report Key | 3915637 |
| Report Source | 07 |
| Date Received | 2014-06-11 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-05-12 |
| Date Mfgr Received | 2014-05-12 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2014-07-28 |
| 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 NSTALEY 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7500 FAST DX REAL-TIME PCR INSTRUMENT |
| Generic Name | INSTRUMENTATION FOR CLINICAL MULTIPL |
| Product Code | NSU |
| Date Received | 2014-06-11 |
| Catalog Number | 4406985 |
| 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 | 2014-06-11 |