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 REAK TIME PCR 4406985 manufactured by Life Technologies Holdings Pte Ltd.
[18064203]
A customer reported a heater block issue on the instrument applied biosystems 7500 fast dx (catalog no. 4406985) with serial no. (b)(4), resulting in incorrect results from an assay run. No pt involvement reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18537464]
Device is an instrument and is not implanted/explanted. The repair was completed by replacing the sample block. The instrument passed all specification tests after the sample block was replaced. This device is used to obtain results for a diagnosis. 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 | 3003673482-2014-00020 |
| MDR Report Key | 3978887 |
| Report Source | 04,07 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-01-16 |
| Date of Event | 2014-01-16 |
| Date Mfgr Received | 2014-01-16 |
| Device Manufacturer Date | 2011-10-01 |
| 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 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 BIOSYSTEMS 7500 FAST DX REAK TIME PCR |
| Generic Name | INSRUMENTATION FOR CLINICAL MULTIPL |
| Product Code | NSU |
| Date Received | 2014-06-27 |
| Catalog Number | 4406985 |
| Operator | HEALTH PROFESSIONAL |
| 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 |