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 BIOSYSTEMS 7500 FAST DX REAL-TIME PCR 4407205 manufactured by Life Technologies Holdings Pte. Ltd..
[4888856]
A customer reported results contained noisy data and spikes in amplification over several cycles after assay run from the instrument, applied biosystems 7500 fast dx (cat. No. 4407205, serial no. (b)(4). This resulted in incorrect assay results. No patient involvement reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12059975]
Device is an instrument and is not implanted/explanted. The instrument investigated on site. The field service engineer (fse) installed new block drive assembly and new camera, a full qualification performed all tests passed, the problem was solved. 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 | 3003673482-2014-00036 |
| MDR Report Key | 3978835 |
| Report Source | 04,07 |
| Date Received | 2014-06-27 |
| Date of Report | 2013-11-06 |
| Date of Event | 2013-11-06 |
| Date Mfgr Received | 2013-11-06 |
| Device Manufacturer Date | 2009-10-01 |
| 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 ROAD, GRAND ISLAND |
| Manufacturer City | NEW YORK NY 14072 |
| Manufacturer Country | US |
| Manufacturer Postal | 14072 |
| Manufacturer Phone | 7167743122 |
| Manufacturer G1 | LIFE TECHNOLOGIES HOLDINGS PTD. LTD. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPLIED BIOSYSTEMS 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 | 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 |